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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.
Trial design
Cohort
Prospective
Treatments tested in this trial
NOM
Other interventionPatients 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 interventionPatients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Surgical Safety and Postoperative Complications
Incidence and severity of perioperative complications classified by the Clavien-Dindo grading system, comparing RO, LE, and endoscopic resection (ESD/EMR).
Distribution of Pathological Response (RO Group Only)
Percentage of patients achieving ypCR, ypTisN0, ypT1-2N0, and ypT3+ in the radical surgery cohort to characterize pathological response after immunotherapy.
Local Regrowth Rate
The proportion of patients experiencing local tumor regrowth in the W\&W group or after local/endoscopic excision.
Overall Survival (OS)
Time from the start of treatment to death from any cause.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: