Gastrointestinal CancerNOMAD-GINCT07775859
NOMAD-GI: Molecular-guided Non-operative Management and Organ Preservation Strategy After Precision Therapy in Gastrointestinal Cancers
An observational study of Gastrointestinal Cancer and Gastric Cancer, run by Peking University Cancer Hospital & Institute.
Trial summary
The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and efficacy of molecular biomarker-guided non-operative management (NOM) and organ preservation strategies after precision therapy in patients with gastrointestinal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Gastric Cancer, Gastroesophageal Junction Cancer
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2031
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with histologically confirmed gastrointestinal cancers who are treated at Peking University Cancer Hospital and who have at least one actionable molecular biomarker relevant to immune checkpoint inhibitor therapy, targeted therapy, or other precision treatment strategies. Eligible participants will be identified from the institutional gastrointestinal oncology clinical practice and research database and enrolled into retrospective or prospective cohorts according to the availability of eligible clinical data and the timing of study enrollment.
Who may be able to join
- Adults aged 18 years or older at the time of study enrollment.
- Histologically confirmed gastrointestinal malignancy, including gastric cancer, gastroesophageal junction cancer, esophageal cancer, or colorectal cancer.
- Presence of at least one molecular biomarker that may support selection of precision therapy, including but not limited to:
- Mismatch repair deficiency or microsatellite instability-high (dMMR/MSI-H);
- Pathogenic or likely pathogenic POLE or POLD1 mutation;
- High programmed death ligand 1 combined positive score (PD-L1 CPS), when applicable to the tumor type and treatment strategy;
Show all 22Show fewer
- Tumor mutational burden-high (TMB-H);
- Epstein-Barr virus-positive status (EBV-positive), when applicable;
- Human epidermal growth factor receptor 2 (HER2) positivity;
- Claudin 18.2 (CLDN18.2) positivity;
- Fibroblast growth factor receptor 2 (FGFR2) alteration;
- Mesenchymal-epithelial transition factor (MET) amplification or other actionable MET alteration;
- Neurotrophic tyrosine receptor kinase (NTRK) gene fusion;
- Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation;
- Other clinically actionable molecular alterations recognized according to contemporary clinical practice.
- Receipt of molecular biomarker-guided precision therapy before assessment for non-operative management or organ-preservation strategy. Precision therapy may include immune checkpoint inhibitor therapy, targeted therapy, or a combination of systemic therapies according to the participant's tumor type, molecular profile, clinical stage, and standard clinical practice.
- After completion or adequate exposure to precision therapy, achievement of a favorable clinical response that may support consideration of non-operative management or organ-preservation strategy, including clinical complete response (cCR), near-complete response (near-cCR), major tumor regression, or other predefined favorable response categories.
- Multidisciplinary team (MDT) evaluation has been performed to determine whether non-operative management, local treatment, organ-preservation strategy, or radical surgery is appropriate.
- Adequate clinical information is available for assessment of treatment response, including appropriate imaging, endoscopic evaluation, pathological evaluation, or other clinically indicated examinations.
- Ability and willingness to comply with the predefined surveillance and follow-up schedule.
- For the prospective cohort, written informed consent is obtained before enrollment and study-specific data collection.
- For the retrospective cohort, eligible clinical data are available in the institutional medical records and may be used according to institutional ethics approval and applicable regulations.
Who cannot join
- Uncontrolled progressive metastatic disease or clinical deterioration that precludes evaluation for the study treatment strategy.
- Patients who are unable to undergo appropriate clinical, radiological, endoscopic, or pathological assessment required for response evaluation or follow-up.
- Previous treatment history or concurrent medical conditions that, in the judgment of the multidisciplinary team, preclude reliable assessment of tumor response or implementation of the predefined surveillance strategy.
- Severe comorbidities or medical conditions that make continued follow-up or additional treatment evaluation clinically inappropriate.
- Inability or unwillingness to comply with the predefined follow-up schedule.
- Withdrawal of informed consent for prospective participants.
- Insufficient clinical information to determine eligibility, treatment response, treatment strategy, or follow-up outcomes.
- Patients with conditions that require immediate radical surgery or other urgent treatment according to multidisciplinary clinical assessment and who cannot safely undergo the predefined study evaluation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Molecular-guided Non-operative Management and Organ Preservation Strategy After Precision Therapy in Gastrointestinal Cancers: A Single-center Bidirectional Cohort Study
The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and efficacy of molecular biomarker-guided non-operative management (NOM) and organ preservation strategies after precision therapy in patients with gastrointestinal cancers.
Patients with actionable molecular biomarkers, including dMMR/MSI-H, POLE mutation, PD-L1 high expression, tumor mutational burden-high (TMB-H), Epstein-Barr virus positivity (EBV+), HER2 positivity, CLDN18.2 positivity, and other actionable genomic alterations, will be enrolled.
Read more
After immune checkpoint inhibitor or targeted therapy, patients achieving favorable clinical responses will undergo multidisciplinary team (MDT) evaluation and receive either non-operative management, local treatment, or radical surgery according to individualized treatment decisions.
The study aims to establish a molecular-driven organ preservation paradigm for gastrointestinal cancers and evaluate whether NOM can provide comparable oncological outcomes while improving functional outcomes and quality of life.
Read the detailed description
The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and clinical effectiveness of molecular biomarker-guided precision therapy followed by non-operative management (NOM) or organ-preservation strategies in patients with gastrointestinal cancers.
The central hypothesis of the study is that a subset of gastrointestinal cancers with favorable molecular characteristics may achieve a deep and durable tumor response after appropriately selected precision therapy. In carefully selected patients with a complete or near-complete clinical response, a multidisciplinary team (MDT) may identify patients in whom radical surgery can potentially be avoided while maintaining acceptable oncological safety and preserving organ function.
The study is designed to investigate a treatment paradigm in which molecular characteristics are integrated with treatment response and clinical characteristics to support individualized treatment decisions. Molecular biomarkers are therefore considered part of a multidimensional decision-making framework rather than isolated determinants of treatment allocation.
Molecular biomarkers in this study are used primarily to guide the selection of precision therapy rather than to directly determine eligibility for non-operative management. The molecular profile may include immune-related biomarkers, such as mismatch repair deficiency or microsatellite instability-high status, pathogenic POLE or POLD1 alterations, high tumor mutational burden, programmed death ligand 1 combined positive score, and Epstein-Barr virus positivity, as well as biomarkers associated with targeted treatment, such as HER2, CLDN18.2, FGFR2, MET, NTRK, KRAS G12C, and other clinically actionable molecular alterations.
The specific precision therapy received by each participant will be determined according to tumor type, disease stage, molecular characteristics, approved indications, contemporary clinical practice, and the treating multidisciplinary team. Precision therapy may include immune checkpoint inhibitors, targeted therapies, chemotherapy combined with immunotherapy or targeted therapy, or other clinically appropriate systemic treatment approaches.
After precision therapy, treatment response will be evaluated using appropriate clinical, radiological, endoscopic, and pathological assessments according to the primary tumor site. Patients with a favorable response, including clinical complete response or near-complete response, may undergo MDT evaluation for potential non-operative management or organ-preservation treatment.
The MDT decision will consider tumor response, primary tumor location, baseline disease characteristics, molecular profile, treatment history, imaging findings, endoscopic findings, pathological findings when available, patient preferences, expected functional consequences of radical surgery, and the feasibility of intensive surveillance.
Patients considered suitable for non-operative management may undergo a structured watch-and-wait or active surveillance strategy. Selected patients with residual or near-complete response may undergo local treatment, including endoscopic resection or local excision, when clinically appropriate. Patients who do not meet criteria for safe organ preservation, who have persistent or progressive disease, or who require radical treatment based on MDT assessment will undergo radical surgery according to standard clinical practice.
The study includes both a retrospective cohort and a prospective cohort. The retrospective cohort will include eligible patients treated before initiation of prospective enrollment for whom sufficient clinical, molecular, treatment, response, and follow-up data are available. The prospective cohort will include eligible participants enrolled after ethics approval and informed consent, followed according to the predefined study surveillance protocol.
The primary research objective is to evaluate the proportion of patients who achieve successful organ preservation without radical surgery after molecular biomarker-guided precision therapy and MDT-directed NOM or organ-preservation treatment. Secondary objectives include evaluation of disease-free survival, overall survival, local tumor regrowth, salvage radical surgery, permanent stoma, treatment-related morbidity, and patient-reported quality of life and organ function.
The study is observational. Treatment selection, including the choice of precision therapy, NOM, organ-preservation treatment, or radical surgery, will be based on clinical decision-making and will not be assigned randomly by the study.
The presence of an actionable molecular biomarker alone does not constitute an indication for non-operative management. Non-operative management or organ-preservation treatment will only be considered after appropriate precision therapy and comprehensive response assessment, and will require MDT evaluation confirming that the anticipated oncological risk is acceptable and that intensive surveillance is feasible.
- Conditions
- Gastrointestinal Cancer, Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Cancer, Colorectal Cancer
- Keywords
- Precision oncology, Molecular biomarkers, Gastrointestinal cancer, Non-operative management, Organ preservation, Immunotherapy, Targeted therapy, Watch and wait, Multidisciplinary treatment
- Medical subject headings
- Gastrointestinal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Molecular-guided NOM/Organ Preservation Cohort | Patients receiving molecular-guided precision therapy followed by multidisciplinary evaluation and managed with: * Watch-and-wait strategy; * Endoscopic resection; * Local excision; * Other organ-preserving approaches. | |
| Radical Surgery Cohort | Patients receiving radical surgical resection after precision therapy. Procedures include: * Radical gastrectomy; * Radical colorectal resection; * Esophagectomy. Participants will not be assigned to a treatment group by the study. The cohort classification will be based on the treatment strategy actually received after precision therapy and MDT evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Organ Preservation Success Rate Without Radical Surgery
The proportion of participants who remain free from radical surgical resection and maintain the originally targeted organ at 3 years after initiation of the non-operative management or organ-preservation strategy. Organ preservation success will be assessed using clinical records, imaging, endoscopic evaluation, pathological evaluation when applicable, and subsequent treatment records.
Measure: Percentage of participants Unit of Measure: Percentage
Measured: 3 years after initiation of the non-operative management or organ-preservation strategy
Secondary outcomes (11)
3-Year Disease-Free Survival as Determined by Clinical, Radiological, Endoscopic, and Pathological Evidence of Disease Recurrence
Disease-free survival is defined as the time from initiation of the non-operative management or organ-preservation strategy, or from radical surgery for participants in the radical surgery cohort, to the first documented local regrowth, local recurrence, regional recurrence, distant metastasis, second primary gastrointestinal malignancy, or death from any cause. Participants without an event at the date of last follow-up will be censored at that date.
Measure: Time to event. Unit of Measure: Months.
Measured: 3 years after initiation of the study treatment strategy
3-Year Overall Survival as Determined by All-Cause Mortality
Overall survival is defined as the time from initiation of the non-operative management or organ-preservation strategy, or from radical surgery for participants in the radical surgery cohort, to death from any cause. Participants who are alive at the date of last follow-up will be censored at that date.
Measure: Time to event. Events: Months.
Measured: 3 years after initiation of the study treatment strategy
3-Year Local Regrowth Rate Determined by Imaging, Endoscopy, and Pathological Evaluation
Local regrowth is defined as the reappearance of viable tumor at or adjacent to the primary tumor site after an initial clinical complete response or near-complete response during the non-operative management or organ-preservation surveillance period. Local regrowth will be assessed by magnetic resonance imaging, computed tomography, endoscopy, biopsy, or other clinically indicated diagnostic procedures.
Measure: Percentage of participants. Unit of Measure: Percentage.
Measured: 3 years after initiation of the non-operative management or organ-preservation strategy
3-Year Salvage Radical Surgery Rate After Initial Non-Operative Management
The proportion of participants initially managed with non-operative management or an organ-preservation strategy who subsequently undergo radical surgery because of local regrowth, persistent residual disease, disease progression, inability to achieve or maintain clinical complete response, or other predefined criteria for treatment failure.
Measure: Percentage of participants. Unit of Measure: Percentage.
Measured: 3 years after initiation of the non-operative management or organ-preservation strategy
3-Year Permanent Stoma Rate
The proportion of participants who have a permanent intestinal stoma at 3 years after initiation of the non-operative management or organ-preservation strategy or radical surgery, as applicable.
Measure: Percentage of participants. Unit of Measure: Percentage.
Measured: 3 years after initiation of the study treatment strategy
Global Health Status/Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Global health status and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The Global Health Status/Quality of Life scale is transformed to a score ranging from 0 to 100. Higher scores indicate better global health status and quality of life.
Measure: Score on a 0 to 100 scale. Unit of Measure: Score.
Measured: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Physical Functioning Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Physical functioning will be assessed using the Physical Functioning scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The score is transformed to a range from 0 to 100. Higher scores indicate better physical functioning.
Measure: Score on a 0 to 100 scale. Unit of Measure: Score.
Measured: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Low Anterior Resection Syndrome Score as Measured by the Low Anterior Resection Syndrome (LARS) Score Questionnaire in Participants With Rectal Cancer
Bowel dysfunction will be assessed using the Low Anterior Resection Syndrome (LARS) Score questionnaire in participants with rectal cancer. The LARS Score ranges from 0 to 42, with higher scores indicating more severe bowel dysfunction. Scores of 0 to 20 indicate no LARS, 21 to 29 indicate minor LARS, and 30 to 42 indicate major LARS.
Measure: Score on a 0 to 42 scale. Unit of Measure: Score.
Measured: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Gastric Cancer-Specific Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Gastric Cancer Module (EORTC QLQ-STO22)
Gastric cancer-specific health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Gastric Cancer Module (EORTC QLQ-STO22). Scores are linearly transformed to a 0 to 100 scale. Higher scores on symptom scales indicate greater symptom burden and worse health-related quality of life.
Measure: Score on a 0 to 42 scale. Unit of Measure: Score.
Measured: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Esophageal Cancer-Specific Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophageal Cancer Module (EORTC QLQ-OES18)
Esophageal cancer-specific health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophageal Cancer Module (EORTC QLQ-OES18). Scores are transformed to a 0 to 100 scale. Higher scores on symptom scales indicate greater symptom burden and worse health-related quality of life.
Measure: Score on a 0 to 100 scale. Unit of Measure: Score.
Measured: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
5-Year Overall Survival as Determined by All-Cause Mortality
Overall survival is defined as the time from initiation of the study treatment strategy to death from any cause. Participants who are alive at the date of last follow-up will be censored at that date.
Measure: Time to event. Unit of Measure: Months.
Measured: 5 years after initiation of the study treatment strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775859
- Sponsor's protocol ID
- NOMAD-GI-001
- Other IDs
- NOMAD-GI Study
- Acronym
- NOMAD-GI
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared upon reasonable request after publication.
Publications
[1] SUNG H, FILHO A M, LAVERSANNE M, et al. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries [J]. CA Cancer J Clin, 2026, 76(4): e70090. [2] SUN K X, LI L, WANG S M, et al. [Cancer incidence and mortality across diverse geographical regions in China, 2024] [J]. Zhonghua Zhong Liu Za Zhi, 2026, 48(3): 400-12. [3] National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer (Version 2.2026). Published March 2026. Accessed August 8, 2026. https://www.nccn.org/guidelines/guidelines-detail?id=1428 [J]. [4] FOKAS E, APPELT A, GLYNNE-JONES R, et al. International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer [J]. Nature Reviews Clinical Oncology, 2021, 18(12): 805-16. [5] HABR-GAMA A, PEREZ R O, NADALIN W, et al. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results [J]. Ann Surg, 2004, 240(4): 711-7; discussion 7-8. [6] MUZNY D M, BAINBRIDGE M N, CHANG K, et al. Comprehensive molecular characterization of human colon and rectal cancer [J]. Nature, 2012, 487(7407): 330-7. [7] SADANANDAM A, LYSSIOTIS C A, HOMICSKO K, et al. A colorectal cancer classification system that associates cellular phenotype and responses to therapy [J]. Nat Med, 2013, 19(5): 619-25. [8] BASS A J, THORSSON V, SHMULEVICH I, et al. Comprehensive molecular characterization of gastric adenocarcinoma [J]. Nature, 2014, 513(7517): 202-9. [9] LE D T, URAM J N, WANG H, et al. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency [J]. N Engl J Med, 2015, 372(26): 2509-20. [10] LE D T, DURHAM J N, SMITH K N, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade [J]. Science, 2017, 357(6349): 409-13.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Molecular-guided Non-operative Management and Organ Preservation Strategy After Precision Therapy in Gastrointestinal Cancers: A Single-center Bidirectional Cohort Study
- ClinicalTrials.gov ID
- NCT07775859
- Acronym / sponsor ID
- NOMAD-GI / NOMAD-GI-001
- Conditions
- Gastrointestinal Cancer, Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Cancer, Colorectal Cancer
- Keywords
- Precision oncology, Molecular biomarkers, Gastrointestinal cancer, Non-operative management, Organ preservation, Immunotherapy, Targeted therapy, Watch and wait
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and efficacy of molecular biomarker-guided non-operative management (NOM) and organ preservation strategies after precision therapy in patients with gastrointestinal cancers.
Patients with actionable molecular biomarkers, including dMMR/MSI-H, POLE mutation, PD-L1 high expression, tumor mutational burden-high (TMB-H), Epstein-Barr virus positivity (EBV+), HER2 positivity, CLDN18.2 positivity, and other actionable genomic alterations, will be enrolled.
After immune checkpoint inhibitor or targeted therapy, patients achieving favorable clinical responses will undergo multidisciplinary team (MDT) evaluation and receive either non-operative management, local treatment, or radical surgery according to individualized treatment decisions.
The study aims to establish a molecular-driven organ preservation paradigm for gastrointestinal cancers and evaluate whether NOM can provide comparable oncological outcomes while improving functional outcomes and quality of life.
Detailed description
The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and clinical effectiveness of molecular biomarker-guided precision therapy followed by non-operative management (NOM) or organ-preservation strategies in patients with gastrointestinal cancers.
The central hypothesis of the study is that a subset of gastrointestinal cancers with favorable molecular characteristics may achieve a deep and durable tumor response after appropriately selected precision therapy. In carefully selected patients with a complete or near-complete clinical response, a multidisciplinary team (MDT) may identify patients in whom radical surgery can potentially be avoided while maintaining acceptable oncological safety and preserving organ function.
The study is designed to investigate a treatment paradigm in which molecular characteristics are integrated with treatment response and clinical characteristics to support individualized treatment decisions. Molecular biomarkers are therefore considered part of a multidimensional decision-making framework rather than isolated determinants of treatment allocation.
Molecular biomarkers in this study are used primarily to guide the selection of precision therapy rather than to directly determine eligibility for non-operative management. The molecular profile may include immune-related biomarkers, such as mismatch repair deficiency or microsatellite instability-high status, pathogenic POLE or POLD1 alterations, high tumor mutational burden, programmed death ligand 1 combined positive score, and Epstein-Barr virus positivity, as well as biomarkers associated with targeted treatment, such as HER2, CLDN18.2, FGFR2, MET, NTRK, KRAS G12C, and other clinically actionable molecular alterations.
The specific precision therapy received by each participant will be determined according to tumor type, disease stage, molecular characteristics, approved indications, contemporary clinical practice, and the treating multidisciplinary team. Precision therapy may include immune checkpoint inhibitors, targeted therapies, chemotherapy combined with immunotherapy or targeted therapy, or other clinically appropriate systemic treatment approaches.
After precision therapy, treatment response will be evaluated using appropriate clinical, radiological, endoscopic, and pathological assessments according to the primary tumor site. Patients with a favorable response, including clinical complete response or near-complete response, may undergo MDT evaluation for potential non-operative management or organ-preservation treatment.
The MDT decision will consider tumor response, primary tumor location, baseline disease characteristics, molecular profile, treatment history, imaging findings, endoscopic findings, pathological findings when available, patient preferences, expected functional consequences of radical surgery, and the feasibility of intensive surveillance.
Patients considered suitable for non-operative management may undergo a structured watch-and-wait or active surveillance strategy. Selected patients with residual or near-complete response may undergo local treatment, including endoscopic resection or local excision, when clinically appropriate. Patients who do not meet criteria for safe organ preservation, who have persistent or progressive disease, or who require radical treatment based on MDT assessment will undergo radical surgery according to standard clinical practice.
The study includes both a retrospective cohort and a prospective cohort. The retrospective cohort will include eligible patients treated before initiation of prospective enrollment for whom sufficient clinical, molecular, treatment, response, and follow-up data are available. The prospective cohort will include eligible participants enrolled after ethics approval and informed consent, followed according to the predefined study surveillance protocol.
The primary research objective is to evaluate the proportion of patients who achieve successful organ preservation without radical surgery after molecular biomarker-guided precision therapy and MDT-directed NOM or organ-preservation treatment. Secondary objectives include evaluation of disease-free survival, overall survival, local tumor regrowth, salvage radical surgery, permanent stoma, treatment-related morbidity, and patient-reported quality of life and organ function.
The study is observational. Treatment selection, including the choice of precision therapy, NOM, organ-preservation treatment, or radical surgery, will be based on clinical decision-making and will not be assigned randomly by the study.
The presence of an actionable molecular biomarker alone does not constitute an indication for non-operative management. Non-operative management or organ-preservation treatment will only be considered after appropriate precision therapy and comprehensive response assessment, and will require MDT evaluation confirming that the anticipated oncological risk is acceptable and that intensive surveillance is feasible.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Molecular-guided NOM/Organ Preservation Cohort | – | –Patients receiving molecular-guided precision therapy followed by multidisciplinary evaluation and managed with: * Watch-and-wait strategy; * Endoscopic resection; * Local excision; * Other organ-preserving approaches. |
| Radical Surgery Cohort | – | –Patients receiving radical surgical resection after precision therapy. Procedures include: * Radical gastrectomy; * Radical colorectal resection; * Esophagectomy. Participants will not be assigned to a treatment group by the study. The cohort classification will be based on the treatment strategy actually received after precision therapy and MDT evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with histologically confirmed gastrointestinal cancers who are treated at Peking University Cancer Hospital and who have at least one actionable molecular biomarker relevant to immune checkpoint inhibitor therapy, targeted therapy, or other precision treatment strategies. Eligible participants will be identified from the institutional gastrointestinal oncology clinical practice and research database and enrolled into retrospective or prospective cohorts according to the availability of eligible clinical data and the timing of study enrollment.
Key inclusion criteria (22 listed)
- Adults aged 18 years or older at the time of study enrollment.
- Histologically confirmed gastrointestinal malignancy, including gastric cancer, gastroesophageal junction cancer, esophageal cancer, or colorectal cancer.
- Presence of at least one molecular biomarker that may support selection of precision therapy, including but not limited to:
- Receipt of molecular biomarker-guided precision therapy before assessment for non-operative management or organ-preservation strategy. Precision therapy may include immune checkpoint inhibitor therapy, targeted therapy, or a combination of systemic therapies according to the participant's tumor type, molecular profile, clinical stage, and standard clinical practice.
- After completion or adequate exposure to precision therapy, achievement of a favorable clinical response that may support consideration of non-operative management or organ-preservation strategy, including clinical complete response (cCR), near-complete response (near-cCR), major tumor regression, or other predefined favorable response categories.
Key exclusion criteria (8 listed)
- Uncontrolled progressive metastatic disease or clinical deterioration that precludes evaluation for the study treatment strategy.
- Patients who are unable to undergo appropriate clinical, radiological, endoscopic, or pathological assessment required for response evaluation or follow-up.
- Previous treatment history or concurrent medical conditions that, in the judgment of the multidisciplinary team, preclude reliable assessment of tumor response or implementation of the predefined surveillance strategy.
- Severe comorbidities or medical conditions that make continued follow-up or additional treatment evaluation clinically inappropriate.
- Inability or unwillingness to comply with the predefined follow-up schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3-Year Organ Preservation Success Rate Without Radical Surgery
Time frame: 3 years after initiation of the non-operative management or organ-preservation strategy
The proportion of participants who remain free from radical surgical resection and maintain the originally targeted organ at 3 years after initiation of the non-operative management or organ-preservation strategy. Organ preservation success will be assessed using clinical records, imaging, endoscopic evaluation, pathological evaluation when applicable, and subsequent treatment records. Measure: Percentage of participants Unit of Measure: Percentage
11 secondary outcomes
3-Year Disease-Free Survival as Determined by Clinical, Radiological, Endoscopic, and Pathological Evidence of Disease Recurrence
Time frame: 3 years after initiation of the study treatment strategy
3-Year Overall Survival as Determined by All-Cause Mortality
Time frame: 3 years after initiation of the study treatment strategy
3-Year Local Regrowth Rate Determined by Imaging, Endoscopy, and Pathological Evaluation
Time frame: 3 years after initiation of the non-operative management or organ-preservation strategy
3-Year Salvage Radical Surgery Rate After Initial Non-Operative Management
Time frame: 3 years after initiation of the non-operative management or organ-preservation strategy
3-Year Permanent Stoma Rate
Time frame: 3 years after initiation of the study treatment strategy
Global Health Status/Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Physical Functioning Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Low Anterior Resection Syndrome Score as Measured by the Low Anterior Resection Syndrome (LARS) Score Questionnaire in Participants With Rectal Cancer
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Gastric Cancer-Specific Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Gastric Cancer Module (EORTC QLQ-STO22)
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
Esophageal Cancer-Specific Quality of Life Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophageal Cancer Module (EORTC QLQ-OES18)
Time frame: Baseline, 6 months, 12 months, 24 months, and 36 months after initiation of the study treatment strategy
5-Year Overall Survival as Determined by All-Cause Mortality
Time frame: 5 years after initiation of the study treatment strategy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background[1] SUNG H, FILHO A M, LAVERSANNE M, et al. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries [J]. CA Cancer J Clin, 2026, 76(4): e70090. [2] SUN K X, LI L, WANG S M, et al. [Cancer incidence and mortality across diverse geographical regions in China, 2024] [J]. Zhonghua Zhong Liu Za Zhi, 2026, 48(3): 400-12. [3] National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer (Version 2.2026). Published March 2026. Accessed August 8, 2026. https://www.nccn.org/guidelines/guidelines-detail?id=1428 [J]. [4] FOKAS E, APPELT A, GLYNNE-JONES R, et al. International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer [J]. Nature Reviews Clinical Oncology, 2021, 18(12): 805-16. [5] HABR-GAMA A, PEREZ R O, NADALIN W, et al. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results [J]. Ann Surg, 2004, 240(4): 711-7; discussion 7-8. [6] MUZNY D M, BAINBRIDGE M N, CHANG K, et al. Comprehensive molecular characterization of human colon and rectal cancer [J]. Nature, 2012, 487(7407): 330-7. [7] SADANANDAM A, LYSSIOTIS C A, HOMICSKO K, et al. A colorectal cancer classification system that associates cellular phenotype and responses to therapy [J]. Nat Med, 2013, 19(5): 619-25. [8] BASS A J, THORSSON V, SHMULEVICH I, et al. Comprehensive molecular characterization of gastric adenocarcinoma [J]. Nature, 2014, 513(7517): 202-9. [9] LE D T, URAM J N, WANG H, et al. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency [J]. N Engl J Med, 2015, 372(26): 2509-20. [10] LE D T, DURHAM J N, SMITH K N, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade [J]. Science, 2017, 357(6349): 409-13.
- Individual participant dataSharing planned: Undecided. Data may be shared upon reasonable request after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer and Gastric Cancer, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lei, M.D. (+8601088196086, lxkpku@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Organ Preservation Success Rate Without Radical Surgery (time frame: 3 years after initiation of the non-operative management or organ-preservation strategy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07775859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.