Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NOM, RO.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Cancer, Colorectal (Colon or Rectal) Cancer, Stomach (Gastric) Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)
Overview
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.
Interventions
- Other 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). - Other RO
Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
Primary outcome measures
- Organ Preservation Rate [Time frame: 3 years after the completion of neoadjuvant immunotherapy.]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University Cancer Hospital — Beijing
Identifiers
NCT: NCT07656740 · NOMIC Trial