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

NCT07656740 | Not Yet Recruiting DMC

• 1 other identifier: NOMIC Trial
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer; Colorectal (Colon or Rectal) Cancer; Stomach (Gastric) Cancer

Keywords

dMMR/MSI-H; POLE-mutated

Outcome Measures

Primary Outcomes (1)

• 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).

  3 years after the completion of neoadjuvant immunotherapy.

Secondary Outcomes (5)

• Surgical Safety and Postoperative Complications

  3 years after the completion of neoadjuvant immunotherapy.

• Distribution of Pathological Response (RO Group Only)

  At the time of radical surgery (typically 4-12 weeks post-immunotherapy).

• Local Regrowth Rate

  Regular follow-up every 3-6 months for up to 3 years.

• Overall Survival (OS)

  Up to 5 years.

• Disease-Free Survival (DFS)

  Up to 5 years from enrollment/treatment initiation.

Study Arms (2)

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).

Other: NOM

Control arm

Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.

Other: RO

Interventions

NOM OTHER

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).

Experimental Cohort (NOM)

RO OTHER

Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.

Control arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Haidian District, 100142, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Colonic Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Stomach Diseases

Central Study Contacts

Lin Wang Prof., M.D.

CONTACT

13910975011; wanglinmd@foxmail.com

Xiaokang Lei Dr., M.D.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): October 15, 2030
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)