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Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib Experimental group | Experimental | In Phase Ib Experimental group,subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) & Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only.Followed by radical surgery for colon cancer. |
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| Phase Ib Control group | Active Comparator | In Phase Ib Control group,subjects will receive two cycles of neoadjuvant immunotherapy with 200 mg of sintilimab per cycle, followed by radical surgery for colon cancer. |
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| Phase III Experimental group | Experimental | In Phase III Experimental group,subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) & Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only. Followed by radical surgery for colon cancer. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery. |
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| Phase III Control group | Active Comparator | In Phase III Control group, subjects will receive radical surgery without neoadjuvant therapy. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | In ARM Phase Ib Control group, Sintilimab will be used twice, q3w. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy. | The proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy. | 1 month after surgery |
| Event Free Survival, EFS(EFS), defined as the time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first. | The time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first. | up to 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| R0 tumor resection rate, defined as the proportion of subjects with R0 excision | The proportion of subjects with R0 excision | 2 week after surgery |
| Overall-survival(OS), defined as the time from randomization to death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| IBI310&Sintilimab | Drug | In ARM Phase Ib&III Experimental group,IBI310&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy. |
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| Radical surgery | Procedure | In ARM Phase Ib&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy |
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The time from randomization to death from any cause
| up to 5 years after surgery |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
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