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

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07656740
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Jun 15, 2029
Completion
Oct 15, 2030

Study Design

Enrollment
50 participants (estimated)

Arms

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

Primary Outcome Measure

Organ Preservation Rate [ Time Frame: 3 years after the completion of neoadjuvant immunotherapy. ]

Central Contacts

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