NCT07656740Not yet recruiting
Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers
Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 15 Jun 2026
- Start date
- 15 Jun 2026
- Primary completion date
- 15 Jun 2029
- Lead sponsor
- Peking University Cancer Hospital & Institute
- NCT number
- NCT07656740
What you commit to
- Study type: Observational
- Planned participants: 50
- From 15 Jun 2026 to the primary completion date, 15 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior receipt of other types of investigational anti-tumor therapies.
- Concomitant diseases or mental health conditions that may interfere with study participation.
Other illness
- 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 \[CVA\]).
Lab values
- Serum creatinine \> 1.5 times upper limit of normal (ULN).
Other
- Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.
- Pregnant or lactating women.
Who the study is looking for
- 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
- 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).
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.