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Report for Clinical Trial NCT03727763

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT): A Single-arm Study

This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.

NCT03727763 Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

2 Interventions

Name: Vemurafenib

Description: 960mg po bid
Type: Drug
Group Labels: 1

FIVC group

Name: Cetuximab

Description: 500mg/m2 iv gtt (14 days per course)
Type: Drug
Group Labels: 1

FIVC group


Primary Outcomes

Description: Evaluation of tumor burden based on RECIST criteria every 4 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.

Measure: Objective Respone Rate(ORR)

Time: up to 55months

Secondary Outcomes

Description: (ETS) rate is defined as 20% reduction in target lesions after the first 6 weeks of treatment (first tumor assessment)

Measure: Early tumor shrinkage (ETS) rate

Time: up to 55months

Other Outcomes

Description: Evaluation of tumor burden based on RECIST criteria every 4 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

Measure: Disease Control Rate (DCR)

Time: up to 55months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT): A Single-arm Study. --- V600E ---

Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT) This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation. --- V600E ---

Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT) This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation. --- V600E --- --- V600E ---

Inclusion Criteria: - Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence; - Patients with BRAF V600E mutation and extended RAS wild type; - Patients have measurable lesions; - Patients are not available for targeted therapy or patients refuse to receive targeted therapy; - Age should be 18-25 years; - Performance status should be 0-2; Exclusion Criteria: - Patients with RAS mutation type; - Patients with brain metastases; - Patients could not tolerate chemotherapy; - Patients have secondary primary tumor Inclusion Criteria: - Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence; - Patients with BRAF V600E mutation and extended RAS wild type; - Patients have measurable lesions; - Patients are not available for targeted therapy or patients refuse to receive targeted therapy; - Age should be 18-25 years; - Performance status should be 0-2; Exclusion Criteria: - Patients with RAS mutation type; - Patients with brain metastases; - Patients could not tolerate chemotherapy; - Patients have secondary primary tumor Colorectal Cancer Colorectal Neoplasms null --- V600E ---

Inclusion Criteria: - Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence; - Patients with BRAF V600E mutation and extended RAS wild type; - Patients have measurable lesions; - Patients are not available for targeted therapy or patients refuse to receive targeted therapy; - Age should be 18-25 years; - Performance status should be 0-2; Exclusion Criteria: - Patients with RAS mutation type; - Patients with brain metastases; - Patients could not tolerate chemotherapy; - Patients have secondary primary tumor Inclusion Criteria: - Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence; - Patients with BRAF V600E mutation and extended RAS wild type; - Patients have measurable lesions; - Patients are not available for targeted therapy or patients refuse to receive targeted therapy; - Age should be 18-25 years; - Performance status should be 0-2; Exclusion Criteria: - Patients with RAS mutation type; - Patients with brain metastases; - Patients could not tolerate chemotherapy; - Patients have secondary primary tumor Colorectal Cancer Colorectal Neoplasms null --- V600E --- --- V600E ---



HPO Nodes


HPO: