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This study is a single arm, single center, phase II, prospective clinical study aimed at exploring the effectiveness and safety of watch and wait strategy guided by dynamic minimal disease residual (MRD) monitoring to achieve clinical complete response after neoadjuvant immunotherapy for locally advanced colorectal cancer with deficient mismatch repair/ microsatellite instability-high (dMMR/MSI-H).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tireilizumab(PD-1 inhibitor) | Drug | Neoadjuvant immunotherapy phase :
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical complete response rate with negative MRD | Clinical complete response rate with negative MRD | 2023/10/30-2026/10/30 |
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Inclusion Criteria:
Exclusion Criteria:
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( 1 ) Patient characteristics
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuan Zhang, doctor | Contact | +86 173 8791 1546 | zhangxuan66@kmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | 650118 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2023 | Jun 16, 2024 |
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| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2023 | Jun 16, 2024 | ICF_001.pdf |