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 Type
OBSERVATIONAL
Enrollment
50
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).
Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
Peking University Cancer Hospital
Beijing, Haidian District, China
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).
Time frame: 3 years after the completion of neoadjuvant immunotherapy.
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).
Time frame: 3 years after the completion of neoadjuvant immunotherapy.
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.
Time frame: At the time of radical surgery (typically 4-12 weeks post-immunotherapy).
Local Regrowth Rate
The proportion of patients experiencing local tumor regrowth in the W\&W group or after local/endoscopic excision.
Time frame: Regular follow-up every 3-6 months for up to 3 years.
Overall Survival (OS)
Time from the start of treatment to death from any cause.
Time frame: Up to 5 years.
Disease-Free Survival (DFS)
Time from the initiation of neoadjuvant immunotherapy to the first documentation of disease recurrence (local, regional, or distant), progression, or death from any cause, comparing the NOM/OPFS group with the RO group.
Time frame: Up to 5 years from enrollment/treatment initiation.
Xiaokang Lei Dr., M.D.
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