Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer (NCT04790448) | Clinical Trial Compass
CompletedPhase 1/2
Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer
China37 participantsStarted 2020-07-27
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed diagnosis of metastatic colorectal cancer
* Histopathological or ctDNA analysis positive for BRAF V600E mutant
* Patients must have had at least undergone one first line treatment with FOLFOX or FOLFIRI or FOLFOXIRI±Bevacizumab before disease progression.
* Measurable and assessable disease according to RECIST 1.1 criteria
* Adequate hematologic function (Platelet\>90×109/L; White blood cells\>3.0×109/L; Neutrophils\>1.5×109/L; Hb\>10.0g/100ml)
* Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminase ≤5 times ULN
* No ascites, normal coagulation function, albumin ≥35g/L
* Child-Pugh class A
* Serum creatinine is less than the upper limit of normal (ULN), or calculated creatinine clearance rate\> 50ml/min (using Cockcroft-Gault equation)
* ECOG performance status of grade 0-2
* Life expectancy\> 3 months
* Patients must provide a signed Informed Consent Form
* Patients must have good compliance till the end of this study
Exclusion Criteria:
* Patients with KRAS and NRAS mutations
* Previously received anti-EGFR monoclonal antibodies or EGFR inhibitors, BRAF inhibitors (with the exception of regorafenib)
* Patients with known contraindications to receiving cetuximab or irinotecan at the planned dose
* Patients with retinal vein occlusion or have current risk factors for retinal vein occlusion (for example, uncontrolled glaucoma or ocular hypertension)
* History of acute or chronic pancreatitis
* History of chro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate from the date of first drug administration until the date of first documented progression or date of death, whichever came first.