Locally Advanced Rectal Cancer (LARC)ctDNA-MRD-RCNCT07393048
Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer
An observational study of Locally Advanced Rectal Cancer (LARC), run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study is a single-center, prospective, observational clinical trial enrolling patients with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0). By collecting tissue and blood samples at multiple timepoints, and integrating multi-omics data including ctDNA mutations, copy number variations, and mtDNA… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Personalized ctDNA-MRD Detection
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2026to 31 Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: "Enrolled subjects must be 18-75 years old, pathologically confirmed with rectal adenocarcinoma (MRI stage II-III), with a tumor inferior margin ≤10 cm, resectable via surgery, ECOG performance status 0-1, normal major organ function, no prior relevant treatment, ability to take oral medications, signed informed consent, and no surgical contraindications. Detailed eligibility criteria can be found in the study protocol." "Subjects with a history of drug allergy, prior cancer treatment, active or past autoimmune disease, immunodeficiency, severe heart disease, other malignant tumors (except low-risk ones) within the past five years, pregnancy or lactation, or other factors affecting safety and compliance will be excluded from this study. Detailed eligibility criteria can be found in the study protocol."
Who may be able to join
- 1: Signed a written informed consent form and voluntarily participated in this study
- 2: Aged 18-75 years, regardless of sex
- 3: Histopathologically confirmed rectal adenocarcinoma
- 4: Clinical stage II-III as assessed by MRI (according to the AJCC 8th edition)
- 5: Distance from the lower tumor margin to the anal verge ≤10 cm
- 6: Surgically resectable
Show all 12Show fewer
- 7: Able to swallow tablets normally
- 8: ECOG PS 0-1
- 9: No prior antitumor therapy for rectal cancer, including radiotherapy, chemotherapy, or surgery
- 10: Scheduled to undergo surgical treatment after completion of neoadjuvant therapy
- 11: No surgical contraindications
- 12: Normal function of major organs, including: complete blood count, blood biochemistry, and coagulation function
Who cannot join
- 1: History of allergy to monoclonal antibodies, any component of tislelizumab, or capecitabine
- 2: Prior or ongoing receipt of any tumor-directed surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc
- 3: Presence of any active autoimmune disease or history of autoimmune disease
- 4: History of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation
- 5: Poorly controlled cardiac clinical symptoms or diseases, including but not limited to: heart failure of NYHA class II or above, unstable angina, myocardial infarction within the past year, or clinically significant supraventricular or ventricular arrhythmia that remains poorly controlled without or despite clinical intervention
- 6: Diagnosis of another malignancy within 5 years prior to the first use of the study drug, except for malignancies with low risk of metastasis or death (5-year survival rate >90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, which may be considered for inclusion
- 7: Pregnant or lactating women
- 8: Other factors, as judged by the investigator, that may lead to premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, alcohol abuse, drug abuse, family or social factors, or any condition that may affect the safety or compliance of the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
HONGWEI YAO, MD, 13611015609, yaohongwei@ccmu.edu.cn
About this study
This study is a single-center, prospective, observational clinical trial enrolling patients with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0). By collecting tissue and blood samples at multiple timepoints, and integrating multi-omics data including ctDNA mutations, copy number variations, and mtDNA profiles, a multi-omics model will be constructed to predict the efficacy of neoadjuvant therapy for rectal cancer.
Read the detailed description
This study is a single-center, prospective, observational clinical trial designed to construct and validate a multi-omics-based predictive model for neoadjuvant treatment efficacy in locally advanced rectal cancer. Patients diagnosed with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0) are enrolled, and tissue and blood samples are dynamically collected at multiple time points. By simultaneously analyzing plasma circulating tumor DNA (ctDNA) somatic mutations, copy number variations, and mitochondrial DNA (mtDNA), a multi-dimensional molecular biomarker system is constructed.The primary objectives of the study include: first, prospectively validating the efficacy of a multi-dimensional molecular biomarker model based on ctDNA mutations, mtDNA, and copy number variations for detecting molecular residual disease (MRD) during neoadjuvant therapy and assessing its sensitivity and specificity in predicting pathological response; second, comparing the sensitivity and specificity of different omics features-ctDNA mutations, mtDNA, copy number variations, alone or in combination-in predicting treatment efficacy after surgery.The secondary objectives are: first, to construct a multi-omics model integrating ctDNA mutations, copy number variations, and mtDNA for dynamically assessing tumor burden changes during neoadjuvant therapy; second, to explore and optimize ctDNA-MRD detection technology, aiming to overcome the high sample volume requirements of traditional methods and improve the detection rate of low-abundance ctDNA.
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Personalized ctDNA-MRD Detection
- Keywords
- ctDNA-MRD, Rectal Cancer, Neoadjuvant Therapy, Predicting the Efficacy, Detection Technology
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized ctDNA-MRD DetectionDiagnostic test
This observational study involves collecting clinical data and biospecimens (peripheral blood and tissue samples) from participants at multiple timepoints. Personalized ctDNA-MRD detection technology, together with copy number variation and mtDNA profiling, is applied to analyze the samples. The primary goal is to predict neoadjuvant therapy efficacy by identifying biomarkers associated with key outcomes, such as tumor regression grade and pathological complete response rate. No experimental drugs or treatments are administered.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Cancer ctDNA-MRD Detection Cohort | This study is an exploratory study, with an expected enrollment of 60 patients diagnosed with stage II-III rectal cancer who are scheduled to undergo neoadjuvant therapy. The sample collection and testing procedures are as follows: Before neoadjuvant therapy: Baseline endoscopic biopsy tissue or paraffin sections:1.1 Two pieces of endoscopic biopsy tissue, approximately 2 mm in diameter, are collected and placed in tissue preservation tubes.1.2 Ten unstained tissue slides are prepared. Peripheral blood collection: 10 mL of blood is collected using cell-free DNA blood collection tubes for the following assays:① ctDNA-customized MRD high-depth sequencing;② ctDNA shallow whole-genome sequencing (sWGS) for monitoring copy number variation (CNV) profiles;③ Mitochondrial DNA (mtDNA) analysis. During neoadjuvant therapy (within 2 weeks after radiotherapy completion): Peripheral blood collection: 10 mL of blood is collected using cell-free DNA blood collection tubes for the followin Receives: Diagnostic Test: Personalized ctDNA-MRD Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) rate
The proportion of patients confirmed to have achieved complete response after neoadjuvant therapy, as assessed by endoscopy, imaging (pelvic MRI/chest-abdominal CT), digital rectal examination, and pathological evaluation. The assessment time point corresponds to T2 (8-14 weeks after the end of neoadjuvant therapy). Complete response requires: normal mucosa on endoscopy with negative biopsy; no residual tumor on imaging; no palpable mass on digital rectal examination; and no viable tumor cells in postoperative pathology (if surgery is performed).
Measured: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
Secondary outcomes (8)
Complete Response Rate (CR)
The proportion of patients confirmed to have achieved complete response after neoadjuvant therapy, as assessed by endoscopy, imaging (pelvic MRI/chest-abdominal CT), digital rectal examination, and pathological evaluation. The assessment time point corresponds to T2 (8-14 weeks after the end of neoadjuvant therapy). Complete response requires: normal mucosa on endoscopy with negative biopsy; no residual tumor on imaging; no palpable mass on digital rectal examination; and no viable tumor cells in postoperative pathology (if surgery is performed).
Measured: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
Major Pathological Response Rate (MPR)
The proportion of patients with ≤10% residual tumor cells and no lymph node metastasis in postoperative pathological examination, assessed at T3 (1 month after radical resection, corresponding to the technical roadmap).
Measured: 1 month after surgery
Objective Response Rate (ORR)
The proportion of patients who achieve complete response (CR) or partial response (PR) after neoadjuvant therapy, assessed at T2 (8-14 weeks after the end of neoadjuvant therapy). Partial response is defined as a ≥30% reduction in tumor size confirmed by endoscopy and imaging, with no new lesions.
Measured: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
Disease-Free Survival (DFS)
The time from the initiation of neoadjuvant therapy to disease recurrence (confirmed by endoscopy/imaging), metastasis, or death from any cause, with follow-up through T4 (surveillance period of 3-6 months, optional) and subsequent long-term follow-up nodes as per the technical roadmap.
Measured: Monitoring Period: Every 3 or 6 months after treatment completion, continued until 1 year.
Overall Survival (OS)
Time from randomization to death from any cause, recurrence, or metastasis. This serves as a gold-standard endpoint for assessing the long-term efficacy of anticancer therapy.
Measured: From the randomization date to the date of death from any cause, disease recurrence, or metastasis-whichever occurred first-assessed over the entire study period with a planned maximum follow-up of 12 months.
Organ Preservation Rate (OPR)
The proportion of patients who avoid radical surgery and retain anal function and rectal organ integrity after neoadjuvant therapy, assessed at T3 (1 month after surgery for operated patients, or 1 month after treatment plan confirmation for non-operated patients, corresponding to the technical roadmap).
Measured: 1 month after surgery
Neoadjuvant Therapy Score for Rectal Cancer (NAR)
At T2 (8-14 weeks after the end of neoadjuvant therapy), the patient's response to neoadjuvant therapy is evaluated using a standardized scoring system that integrates endoscopic findings, imaging regression, and tumor marker levels.
Measured: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
Quality of Life (QoL)
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Colorectal Cancer-Specific Module (EORTC QLQ-CR29) to evaluate physical function, psychological status, and bowel-related quality of life. The EORTC QLQ-C30 uses a 0-100 scale where higher scores in functional domains indicate better function, and higher scores in symptom domains indicate worse symptoms. The EORTC QLQ-CR29 uses a 0-100 scale where higher scores in symptom domains indicate worse bowel/rectal symptoms.
Measured: Baseline (T0), within 2 weeks after completion of radiotherapy (T1), 8-12 weeks after completion of radiotherapy (T2), and 4 weeks after surgery or after final treatment regimen determination (T3), through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal Cancer (LARC)Studies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Hongwei, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393048
- Sponsor's protocol ID
- MR-11-26-002019
- Acronym
- ctDNA-MRD-RC
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT07393048
- Acronym / sponsor ID
- ctDNA-MRD-RC / MR-11-26-002019
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Keywords
- ctDNA-MRD, Rectal Cancer, Neoadjuvant Therapy, Predicting the Efficacy, Detection Technology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Feb 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.
This study is a single-center, prospective, observational clinical trial enrolling patients with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0). By collecting tissue and blood samples at multiple timepoints, and integrating multi-omics data including ctDNA mutations, copy number variations, and mtDNA profiles, a multi-omics model will be constructed to predict the efficacy of neoadjuvant therapy for rectal cancer.
Detailed description
This study is a single-center, prospective, observational clinical trial designed to construct and validate a multi-omics-based predictive model for neoadjuvant treatment efficacy in locally advanced rectal cancer. Patients diagnosed with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0) are enrolled, and tissue and blood samples are dynamically collected at multiple time points. By simultaneously analyzing plasma circulating tumor DNA (ctDNA) somatic mutations, copy number variations, and mitochondrial DNA (mtDNA), a multi-dimensional molecular biomarker system is constructed.The primary objectives of the study include: first, prospectively validating the efficacy of a multi-dimensional molecular biomarker model based on ctDNA mutations, mtDNA, and copy number variations for detecting molecular residual disease (MRD) during neoadjuvant therapy and assessing its sensitivity and specificity in predicting pathological response; second, comparing the sensitivity and specificity of different omics features-ctDNA mutations, mtDNA, copy number variations, alone or in combination-in predicting treatment efficacy after surgery.The secondary objectives are: first, to construct a multi-omics model integrating ctDNA mutations, copy number variations, and mtDNA for dynamically assessing tumor burden changes during neoadjuvant therapy; second, to explore and optimize ctDNA-MRD detection technology, aiming to overcome the high sample volume requirements of traditional methods and improve the detection rate of low-abundance ctDNA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal Cancer ctDNA-MRD Detection Cohort | – | Diagnostic Test: Personalized ctDNA-MRD DetectionThis study is an exploratory study, with an expected enrollment of 60 patients diagnosed with stage II-III rectal cancer who are scheduled to undergo neoadjuvant therapy. The sample collection and testing procedures are as follows: Before neoadjuvant therapy: Baseline endoscopic biopsy tissue or paraffin sections:1.1 Two pieces of endoscopic biopsy tissue, approximately 2 mm in diameter, are collected and placed in tissue preservation tubes.1.2 Ten unstained tissue slides are prepared. Peripheral blood collection: 10 mL of blood is collected using cell-free DNA blood collection tubes for the following assays:① ctDNA-customized MRD high-depth sequencing;② ctDNA shallow whole-genome sequencing (sWGS) for monitoring copy number variation (CNV) profiles;③ Mitochondrial DNA (mtDNA) analysis. During neoadjuvant therapy (within 2 weeks after radiotherapy completion): Peripheral blood collection: 10 mL of blood is collected using cell-free DNA blood collection tubes for the followin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- "Enrolled subjects must be 18-75 years old, pathologically confirmed with rectal adenocarcinoma (MRI stage II-III), with a tumor inferior margin ≤10 cm, resectable via surgery, ECOG performance status 0-1, normal major organ function, no prior relevant treatment, ability to take oral medications, signed informed consent, and no surgical contraindications. Detailed eligibility criteria can be found in the study protocol." "Subjects with a history of drug allergy, prior cancer treatment, active or past autoimmune disease, immunodeficiency, severe heart disease, other malignant tumors (except low-risk ones) within the past five years, pregnancy or lactation, or other factors affecting safety and compliance will be excluded from this study. Detailed eligibility criteria can be found in the study protocol."
Key inclusion criteria (12 listed)
- 1: Signed a written informed consent form and voluntarily participated in this study
- 2: Aged 18-75 years, regardless of sex
- 3: Histopathologically confirmed rectal adenocarcinoma
- 4: Clinical stage II-III as assessed by MRI (according to the AJCC 8th edition)
- 5: Distance from the lower tumor margin to the anal verge ≤10 cm
Key exclusion criteria (8 listed)
- 1: History of allergy to monoclonal antibodies, any component of tislelizumab, or capecitabine
- 2: Prior or ongoing receipt of any tumor-directed surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc
- 3: Presence of any active autoimmune disease or history of autoimmune disease
- 4: History of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation
- 5: Poorly controlled cardiac clinical symptoms or diseases, including but not limited to: heart failure of NYHA class II or above, unstable angina, myocardial infarction within the past year, or clinically significant supraventricular or ventricular arrhythmia that remains poorly controlled without or despite clinical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized ctDNA-MRD DetectionThis observational study involves collecting clinical data and biospecimens (peripheral blood and tissue samples) from participants at multiple timepoints. Personalized ctDNA-MRD detection technology, together with copy number variation and mtDNA profiling, is applied to analyze the samples. The primary goal is to predict neoadjuvant therapy efficacy by identifying biomarkers associated with key outcomes, such as tumor regression grade and pathological complete response rate. No experimental drugs or treatments are administered. | Diagnostic test | Rectal Cancer ctDNA-MRD Detection Cohort |
Primary outcome
Complete Response (CR) rate
Time frame: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
The proportion of patients confirmed to have achieved complete response after neoadjuvant therapy, as assessed by endoscopy, imaging (pelvic MRI/chest-abdominal CT), digital rectal examination, and pathological evaluation. The assessment time point corresponds to T2 (8-14 weeks after the end of neoadjuvant therapy). Complete response requires: normal mucosa on endoscopy with negative biopsy; no residual tumor on imaging; no palpable mass on digital rectal examination; and no viable tumor cells in postoperative pathology (if surgery is performed).
8 secondary outcomes
Complete Response Rate (CR)
Time frame: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
Major Pathological Response Rate (MPR)
Time frame: 1 month after surgery
Objective Response Rate (ORR)
Time frame: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
Disease-Free Survival (DFS)
Time frame: Monitoring Period: Every 3 or 6 months after treatment completion, continued until 1 year.
Overall Survival (OS)
Time frame: From the randomization date to the date of death from any cause, disease recurrence, or metastasis-whichever occurred first-assessed over the entire study period with a planned maximum follow-up of 12 months.
Organ Preservation Rate (OPR)
Time frame: 1 month after surgery
Neoadjuvant Therapy Score for Rectal Cancer (NAR)
Time frame: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
Quality of Life (QoL)
Time frame: Baseline (T0), within 2 weeks after completion of radiotherapy (T1), 8-12 weeks after completion of radiotherapy (T2), and 4 weeks after surgery or after final treatment regimen determination (T3), through study completion, an average of 1 year
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 21 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Cancer (LARC), run by Beijing Friendship Hospital at 1 site in China.
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 12 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yao Hongwei Professor, Doctoral Degree (13611015609, yaohongwei@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) rate (time frame: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.