Combination treatment for advanced colorectal cancer with BRAF V600E mutation
A Randomized, Multicenter, Controlled Study of Irinotecan Hydrochloride Liposome Injection (Ⅱ) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer
This study is testing a new combination treatment for advanced colorectal cancer with a specific mutation to see if it works better than the usual treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Drugs / interventions | radiation, Cetuximab, chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06603376 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a combination treatment regimen of FOLFIRI, Vemurafenib, and Cetuximab for patients with advanced colorectal cancer harboring the BRAFV600E mutation. The study aims to compare this innovative approach against the current standard treatment to evaluate its efficacy and safety. By utilizing a randomized, controlled design, the trial seeks to validate previous findings that suggested significant therapeutic benefits from this combination therapy. Eligible participants will include those who have not received systemic therapy and have measurable lesions as defined by RECIST criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with advanced colorectal adenocarcinoma and confirmed BRAFV600E mutations.
Not a fit: Patients who have previously received systemic therapy for their cancer or those with performance status above 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective first-line therapy option for patients with BRAFV600E-mutant advanced colorectal cancer.
How similar studies have performed: Previous studies have shown promising results with similar combination therapies in this patient population, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology. * Patients with BRAFV600E mutation confirmed by tissue or blood testing. * Patients who have not received systemic therapy or who have experienced metastasis or recurrence 12 months after completing adjuvant therapy. * Patients must have at least one measurable lesion according to RECIST 1.1 criteria. * Patients who received local radiotherapy at least 3 weeks before the first drug treatment are allowed to enroll, but lesions evaluated by RECIST should not be within the radiation field. * Patients aged ≥18 years and ≤80 years. * ECOG performance status of 0-2. * Expected survival of ≥12 weeks. * Patients must have the ability to understand and voluntarily sign a written informed consent. * Women of childbearing potential must have a negative pregnancy test within 7 days prior to the start of treatment. During the study, both the patient and their partner must use contraception. Exclusion Criteria: * Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to the first dose of the study drug. * Patients with hypersensitivity to any component of the study regimen. * Patients who are planning to conceive or are already pregnant. * Patients with brain metastases who cannot accurately describe their condition. * Patients with the following conditions within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina, congestive heart failure greater than NYHA Class 2, uncontrolled arrhythmias, etc. * Abnormal laboratory test results: * Absolute neutrophil count (ANC) \<1,500/mm³; * Platelet count \<75,000/mm³; * Total bilirubin \>1.5 times the upper limit of normal (ULN); ALT (alanine aminotransferase) and AST (aspartate aminotransferase) \>2.5 times ULN (for patients with liver metastasis \>5 times ULN); Creatinine \>1.5 times ULN; * Patients who have had any cancer other than advanced colorectal cancer within five years prior to the start of the study treatment. Exceptions include cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors. * Patients with a history of drug abuse, substance abuse, or alcohol dependence. * Patients who are legally incapacitated or have limited civil capacity. * Any other conditions deemed unsuitable for enrollment by the investigator.
Where this trial is running
Shanghai
- Shanghai Changzheng Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Yuan-Sheng Zang, Professor — Shanghai Changzheng Hospital
- Study coordinator: Zhan Wang, Professor
- Email: 13916229609@139.com
- Phone: 86-13916229609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.