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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| Control arm | Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 years after the completion of neoadjuvant immunotherapy. |
| Distribution of Pathological Response (RO Group Only) |
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Inclusion Criteria:
Retrospective Cohort Inclusion Criteria
Prospective Cohort Inclusion Criteria
Exclusion Criteria:
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Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Wang Prof., M.D. | Contact | 13910975011 | wanglinmd@foxmail.com | |
| Xiaokang Lei Dr., M.D. | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Haidian District | 100142 | China |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D003110 | Colonic Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| RO | Other | Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data. |
|
Percentage of patients achieving ypCR, ypTisN0, ypT1-2N0, and ypT3+ in the radical surgery cohort to characterize pathological response after immunotherapy. |
| 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. | 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. | 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. | Up to 5 years from enrollment/treatment initiation. |
| D005767 |
| Gastrointestinal Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |