This prospective, multicenter, single arm clinical trial was designed to evaluate the efficacy and safety of Vemurafenib in combination with Irinotecan and Cetuximab in the treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer.
PRIMARY OBJECTIVES: To evaluate the Overall Response Rate (ORR) of v-raf murine sarcoma viral oncogene homolog B (BRAF) V600E mutant metastatic colorectal cancer patients treated with Vemurafenib in combination with Irinotecan and Cetuximab (VIC regimen). SECONDARY OBJECTIVES: To evaluate the Progression Free Survival (PFS), Overall Survival (OS), safety and toxicity of VIC regimen in the treatment of BRAF V600E mutant colon cancer. EXPLORATORY OBJECTIVES: Mechanism of primary and secondary resistance to VIC regimen in the treatment of BRAF V600E mutant colon cancer. OUTLINE: Patients receive Cetuximab and Irinotecan intravenously on day 1 and Vemurafenib orally (PO) twice daily (BID) on days 1 to 14. Courses are repeated every 2 weeks in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Route of administration: Intravenous
Route of administration: Intravenous
Route of administration: Oral
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Overall response rate from the date of first drug administration until the date of first documented progression or date of death, whichever came first.
The proportion of patients who achieved a complete or partial response as their best overall response based on RECIST v1.1 criteria
Time frame: up to 17 months
Progression free survival from the date of first drug administration until the date of first documented progression or date of death, whichever came first.
The length of time during and after the treatment of the disease, that a patient lives with the disease without its aggravation
Time frame: up to 17 months
Overall Survival from the date of first drug administration until the date of death from any cause.
The length of time from the start of treatment that patients diagnosed are still alive
Time frame: up to 17 months
Number of patients with adverse events and severity according to NCI CTCAE v5.0
Summary of the Adverse events experienced during treatment related to the drug used in this study
Time frame: up to 6 months
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