Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07656740
NCT07656740Not yet recruitingNot Applicable

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

Peking University Cancer Hospital & Institute1 site in 1 country50 target enrollmentStarted: June 15, 2026Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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-
  • •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.

Investigators

Sponsor
Peking University Cancer Hospital & Institute
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiaokang Lei

Principal Investigator

Peking University Cancer Hospital & Institute

Study Sites (1)

Loading locations...

Similar Trials

Active, not recruiting
Not Applicable
A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 YearsEpstein-Barr Virus (EBV)Healthy Volunteers
NCT07536048Sanofi Pasteur, a Sanofi Company100
Recruiting
Not Applicable
An observational study was conducted in many countries to collect data regarding the current treatment practices and their outcomes in a patient with weak immunity who was admitted to the intensive care unit with severe difficulty in breathing for improvement in future treatment practices.
CTRI/2024/01/061901Groupe de Recherche respiratoire en Réanimation Onco Hématologique10,000
Recruiting
Phase 2
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Advanced Liver Cancers (Morpheus-Liver)
2023-506611-17-00F. Hoffmann-La Roche AG29
Recruiting
Phase 2
A Seamless Phase II/III, Observer-blind, to Evaluate Immunogenicity and Safety of Chikungunya Virus Vaccine in Healthy Subjects 12-65Years of Age.Active Immunisation for Chikungunya Virus Infection
NCT07555392Bharat Biotech International Limited1,000
Active, not recruiting
Phase 4
A clinical study to assess the safety and immunogenicity of BEs Pneumococcal vaccine when administered as a single dose to five years and above of age.
CTRI/2025/03/083102Biological E.Limited1,200