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To explore the efficacy and safety of Cetuximab in combination with dabrafenib and Tislelizumab in BRAF mutated treatment of advanced colorectal cancer
Due to Encorafenib has not been marketed in China, it is difficult to benefit patients, and there are no reported studies of Dabrafenib, also a BRAF inhibitor, in combination with anti-EGFR monoclonal antibody and immunotherapy in BRAF mutated mCRC. Therefore, we intend to use Dabrafenib in combination with cetuximab and Tislelizumab in the treatment of BRAF V600E mutated patients with advanced colorectal cancer to observe the initial efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced CRC | Experimental | Patients with BRAF Mutated Advanced CRC were given Cetuximab in Combination With Dabrafenib and Tislelizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab Dabrafenib Tislelizumab | Drug | Dabrafenib 150mg,BID, Cetuximab 250mg/m2, Tislelizumab 200mg Treatment every three 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 Combine With Immunotherapy and 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wangxia Lv | Contact | 13757141026 | lvwangxia@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wangxia Lv | Zhejiang Cancer Institute & Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Institute & Hospital | Hangzhou | Zhejing | China |
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| Overall survival time |
OS was calculated from the date of pharmacy to death from any cause. |
| up to 36 months |