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The study is being conducted to evaluate the safety and efficacy of Adebrelimab and SHR-8068 in combination with chemoradiotherapy in subjects with rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Patients will receive radiotherapy and Adebrelimab in combination with SHR-8068 and chemotherapy as perioperative treatment. |
|
| Cohort 2 | Experimental | Patients will receive radiotherapy and Adebrelimab combined with chemotherapy as perioperative treatment. |
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| Cohort 3 | Experimental | Patients will receive radiotherapy plus chemotherapy as perioperative treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab in combination with SHR-8068 and chemotherapy | Drug | Adebrelimab in combination with SHR-8068 and chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: pCR (Pathological Complete Response) rate | Evaluated by investigators. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Clinical complete response (cCR) rate | Evaluated by investigators per RECIST v1.1. | 60 months |
| Phase II: Disease-free survival (DFS) | Evaluated by investigators per RECIST v1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanpei Huang | Contact | +86-021-61053363 | chuanpei.huang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
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| Adebrelimab combined with chemotherapy | Drug | Adebrelimab combined with chemotherapy. |
|
| Chemotherapy | Drug | Chemotherapy. |
|
| 60 months |
| Phase II: EFS (Event Free Survival) | Evaluated by investigators per RECIST v1.1. | 60 months |
| Phase II: Tumor regression grade (TRG) | Evaluated by investigators per RECIST v1.1. | 60 months |
| Phase II: R0 resection rate | Evaluated by investigators per RECIST v1.1. | 60 months |
| Phase II: length of hospital stay | Evaluated by investigators per RECIST v1.1. | 60 months |
| Phase II: Overall survival (OS) | Evaluated by investigators per RECIST v1.1. | 60 months |
| Phase II: Perioperative mortality (within 30 days and 90 days after surgery) | Evaluated by investigators per RECIST v1.1. | 60 months |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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