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A phase II study to assess the efficacy and safety of Surufatinib combined with Sintilimab as a second-line treatment in patients with advanced MSS-Type CRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surufatinib plus Sintilimab | Experimental | Drug: Surufatinib plus Sintilimab Surufatinib will be given orally. Sintilimab will be given intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib | Drug | Surufatinib(250mg ,qd,po)+Sintilimab(200mg,q3w,iv),21 days for a cycle.The curative effect was evaluated every 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | CR + PR rate according to the RECIST version 1.1 guidelines. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | To assess the efficacy of Surufatinib Combined With Chemotherapy as second-line therapy to Advanced CRC, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). | up to 12 months |
| Overall survival time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zengqing Guo | Contact | 86-13905918836 | gzq_005@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China, Fujian | Recruiting | Fuzhou | Fujian | 350014 | China |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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|
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines. |
| up to 36 months |
| Assess the anti-tumor activity:DCR | Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines. | up to 12 months |