SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03727763

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Single Center Clinical Study of FOLFIRI With Vemurafenib and Cetuximab in Advanced Colorectal Cancer Patients With BRAF V600E Mutation.

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

FIVC group

Name: Cetuximab

Description: 500mg/m2 iv gtt (14 days per course)

Type: Drug

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

Single Group Assignment


There is one SNP

SNPs


1 V600E

A Single Center Clinical Study of FOLFIRI With Vemurafenib and Cetuximab in Advanced Colorectal Cancer Patients With BRAF V600E Mutation.. FIVC in Advanced Colorectal Cancer Patients With BRAF V600E Mutation. --- V600E ---

A Single Center Clinical Study of FOLFIRI With Vemurafenib and Cetuximab in Advanced Colorectal Cancer Patients With BRAF V600E Mutation.. FIVC in Advanced Colorectal Cancer Patients With BRAF V600E Mutation. --- V600E --- --- V600E ---

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 ---

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:
Neoplasm of the large intestine
Genes 71
FOXE1 PMS1 CDKN2A KRAS MST1 TGFBR2 STK11 MSH6 TCF4 BMPR1A PMS2 KLLN MLH3 DLC1 NRAS BRCA1 BRCA2 PDGFRA DOCK8 PIK3CA GPR35 POLD1 NTHL1 POLE SRC BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 AKT1 RPS19 RPS20 HABP2 MSH2 FGFR3 MSH3 KEAP1 GREM1 MINPP1 SEMA4A CTNNB1 DCC BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM DICER1 RNF43 PALLD EP300 PALB2 SEC23B MUTYH SDHA TP53 SDHB SDHC SDHD AXIN2 SMAD4 FAN1