This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
960mg po bid
500mg/m2 iv gtt (14 days per course)
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective Response Rate(ORR)
Evaluation of tumor burden based on RECIST criteria every 3 cycles(each cycle is 14 days), ORR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response and partial response.
Time frame: up to 55 months
Disease Control Rate (DCR)
Evaluation of tumor burden based on RECIST criteria every 3 cycles(each cycle is 14 days), and DCR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response, partial response and stable disease
Time frame: up to 55 months
Progression-free survival
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks
Time frame: Time from treatment beginning until the date of first documented progression, assessed up to 55 months
Overall survival
From date of treatment beginning until the date of death from any cause, through study completion, an average of 6 weeks
Time frame: Time from treatment beginning until date of death from any cause, assessed up to 55 months
adverse events
Incidence of Treatment-related adverse Events
Time frame: Through study completion, an average of 4 weeks
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