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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University Cancer Hospital & Institute

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • NOM
  • RO

Treatment groups

50 Participants
are divided into 2 treatment groups