Gastrointestinal CancerNOMICNCT07656740
Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers
An observational study of Gastrointestinal Cancer and Colorectal (Colon or Rectal) Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Cancer, Colorectal (Colon or Rectal) Cancer, Stomach (Gastric) Cancer
- What is being tested?
- NOM and RO
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 15 Oct 2030
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.
Who may be able to join
- Retrospective Cohort Inclusion Criteria
- Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
- Completed prior immunotherapy.
- No evidence of distant metastasis.
- Managed with W\&W, LE, endoscopic surgery, or radical operation after treatment.
- Prospective Cohort Inclusion Criteria
Show all 11Show fewer
- Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Immunotherapy status: naive, currently receiving, or completed treatment, and evaluated by the PKUCH-NOMIC research group as cCR/near-cCR or Non-cCR (≤ ymrT2N0).
- No evidence of distant metastasis.
- Absence of emergencies requiring immediate surgery (e.g., hemorrhage, perforation, obstruction).
Who cannot join
- Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.
- Serum creatinine > 1.5 times upper limit of normal (ULN).
- History of pelvic radiation therapy.Inability to tolerate MRI examinations.
- History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).
- Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack [TIA], cerebral vascular accident [CVA]).
- Prior receipt of other types of investigational anti-tumor therapies.
- Pregnant or lactating women.
- Concomitant diseases or mental health conditions that may interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaokang Lei Dr., M.D. contact
China1 site
Peking University Cancer Hospital
Beijing, Haidian District, 100142
Xiaokang Lei Dr., M.D., 18811181993, lxkpku@163.com
About this study
Official title: Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)
This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR ($\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR). Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
- Being tested
- NOM, RO
- Keywords
- dMMR/MSI-H, POLE-mutated
- Medical subject headings
- Gastrointestinal Neoplasms, Colonic Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOMOther
Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0) may undergo local excision (LE) or endoscopic resection (ESD/EMR).
ROOther
Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cohort (NOM) | Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR). Receives: Other: NOM | |
| Control arm | Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data. Receives: Other: RO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ Preservation Rate
The proportion of patients successfully managed with NOM without the need for supplementary radical surgery, loss of organ function, or a permanent stoma (specifically for rectal cancer patients).
Measured: 3 years after the completion of neoadjuvant immunotherapy.
Secondary outcomes (5)
Surgical Safety and Postoperative Complications
Incidence and severity of perioperative complications classified by the Clavien-Dindo grading system, comparing RO, LE, and endoscopic resection (ESD/EMR).
Measured: 3 years after the completion of neoadjuvant immunotherapy.
Distribution of Pathological Response (RO Group Only)
Percentage of patients achieving ypCR, ypTisN0, ypT1-2N0, and ypT3+ in the radical surgery cohort to characterize pathological response after immunotherapy.
Measured: At the time of radical surgery (typically 4-12 weeks post-immunotherapy).
Local Regrowth Rate
The proportion of patients experiencing local tumor regrowth in the W\&W group or after local/endoscopic excision.
Measured: Regular follow-up every 3-6 months for up to 3 years.
Overall Survival (OS)
Time from the start of treatment to death from any cause.
Measured: Up to 5 years.
Disease-Free Survival (DFS)
Time from the initiation of neoadjuvant immunotherapy to the first documentation of disease recurrence (local, regional, or distant), progression, or death from any cause, comparing the NOM/OPFS group with the RO group.
Measured: Up to 5 years from enrollment/treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaokang Lei, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656740
- Sponsor's protocol ID
- NOMIC Trial
- Acronym
- NOMIC
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)
- ClinicalTrials.gov ID
- NCT07656740
- Acronym / sponsor ID
- NOMIC / NOMIC Trial
- Keywords
- dMMR/MSI-H, POLE-mutated
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Oct 2030 (estimated)
- First posted
- 18 Jun 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 is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR ($\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR). Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Cohort (NOM) | – | Other: NOMPatients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR). |
| Control arm | – | Other: ROPatients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.
Key inclusion criteria (11 listed)
- Retrospective Cohort Inclusion Criteria
- Prospective Cohort Inclusion Criteria
Key exclusion criteria (8 listed)
- Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.
- Serum creatinine > 1.5 times upper limit of normal (ULN).
- History of pelvic radiation therapy.Inability to tolerate MRI examinations.
- History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).
- Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack [TIA], cerebral vascular accident [CVA]).
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 |
|---|---|---|
| NOMPatients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0) may undergo local excision (LE) or endoscopic resection (ESD/EMR). | Other | Experimental Cohort (NOM) |
| ROPatients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data. | Other | Control arm |
Primary outcome
Organ Preservation Rate
Time frame: 3 years after the completion of neoadjuvant immunotherapy.
The proportion of patients successfully managed with NOM without the need for supplementary radical surgery, loss of organ function, or a permanent stoma (specifically for rectal cancer patients).
5 secondary outcomes
Surgical Safety and Postoperative Complications
Time frame: 3 years after the completion of neoadjuvant immunotherapy.
Distribution of Pathological Response (RO Group Only)
Time frame: At the time of radical surgery (typically 4-12 weeks post-immunotherapy).
Local Regrowth Rate
Time frame: Regular follow-up every 3-6 months for up to 3 years.
Overall Survival (OS)
Time frame: Up to 5 years.
Disease-Free Survival (DFS)
Time frame: Up to 5 years from enrollment/treatment initiation.
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 18 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Xiaokang Lei Dr., M.D. contact
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 Gastrointestinal Cancer and Colorectal (Colon or Rectal) Cancer, run by Peking University Cancer Hospital & Institute 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 11 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 18 Jun 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 Lin Wang Prof., M.D. (13910975011, wanglinmd@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ Preservation Rate (time frame: 3 years after the completion of neoadjuvant immunotherapy.). 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 18 Jun 2026.