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NCT07656740

Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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 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.

Official title: Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-06-15

Completion Date

2030-10-15

Last Updated

2026-06-18

Healthy Volunteers

No

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.

Locations (1)

Peking University Cancer Hospital

Beijing, Haidian District, China