Colorectal Cancer
Conditions
Brief summary
In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival.
Interventions
DRUGVIC
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
Bevacizumab Plus Doublet or Triplet Chemotherapy
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤80 years old * Histologically confirmed colorectal adenocarcinoma * Histologically confirmed BRAFV600E mutated and RAS wild-type * Initially unresectable metastatic or local CRC * ECOG performance status of 0-1 and life expectancy ≥3 months * adequate hepatic, renal, and hematologic function
Exclusion criteria
* Previously taken any targeted therapy, chemotherapy, intervention therapy, or radiotherapy for CRC within 6 months * Other cancers (with the exception of cervical cancer in situ and squamous cell carcinoma of the skin) within the previous 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 6 months | the proportion of patients with complete response or partial response. |
| progression-free survival | 3 years | time from first study treatment to the first documented progression disease or death, whichever occurred first |
| overall survival | 3 years | time from first study treatment to death from any cause. |
Countries
China
Contacts
Primary ContactJianmin Xu, MD
Outcome results
None listed