RecruitingPhase 2NCT06603376

Irinotecan Hydrochloride Liposome Injection (Ⅱ) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer

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

Sponsor

Shanghai Changzheng Hospital

Enrollment

75 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Carcinoma

Summary

Based on the upstream signaling features of BRAFV600E and the bypass feedback mechanisms, considering the pro-apoptotic effects of chemotherapy and the synergistic effects of targeted therapy, previous IMPROVEMENT trial creatively explored a balanced chemotherapy-targeted combination approach (FOLFIRI + Vemurafenib + Cetuximab) in advanced colorectal cancer patients with BRAF V600E mutaiton using a signle-arm study design, demonstrating significant therapeutic efficacy in these patietns . To further validate the effectiveness and safety of this regimen and to solidify its clinical value, it is crucial to conduct a randomized, controlled trial. Investigators plan to use the current standard regimen as a control to compare this strategy (FOLFIRI + Vemurafenib + Cetuximab) on a large cohort of patients with BRAFV600E-mutant advanced colorectal cancer in the first-line setting, focusing on its efficacy and safety.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new first-line chemotherapy combination — liposomal irinotecan plus standard FOLFOX chemotherapy, along with targeted drugs (vemurafenib and cetuximab) — for patients with advanced colorectal cancer that has a specific mutation called BRAF V600E, which makes the cancer more aggressive and harder to treat. **You may be eligible if...** - You have advanced (metastatic or locally unresectable) colorectal cancer confirmed by biopsy or cell testing - Your cancer has the BRAF V600E mutation confirmed by tissue or blood testing - You have not received prior systemic treatment, OR your cancer came back more than 12 months after completing adjuvant (after-surgery) chemotherapy - You have at least one measurable tumour according to standard criteria - You are between 18 and 80 years old with good general health (ECOG 0–2) - Your expected survival is at least 12 weeks - Women of childbearing potential must have a negative pregnancy test and use contraception **You may NOT be eligible if...** - You had major surgery or serious injury in the past 4 weeks - You are allergic to any component of the study drug regimen - You are pregnant or planning to conceive - You have brain metastases that affect your ability to communicate clearly - You had a heart attack, severe irregular heartbeat, or other serious heart conditions in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFOLFIRI + Vemurafenib + Cetuximab

Liposomal Irinotecan Hydrochloride Injection (II): 60 mg/m², intravenous infusion over at least 90 minutes, on day 1; Leucovorin: 400 mg/m², intravenous infusion over 2 hours, on day 1; 5-FU: 400 mg/m², intravenous bolus; 5-FU: 2400 mg/m², continuous infusion over 46-48 hours, on day 1; Cetuximab: 500 mg/m², intravenous infusion over at least 2 hours, on day 1; Vemurafenib: 720 mg, orally twice daily. Repeat every 2 weeks.

DRUGFOLFIRI ± Bevacizumab

Liposomal Irinotecan Hydrochloride Injection (II): 60 mg/m², intravenous infusion over at least 90 minutes, on day 1; Leucovorin: 400 mg/m², intravenous infusion over 2 hours, on day 1; 5-FU: 400 mg/m², intravenous bolus; 5-FU: 2400 mg/m², continuous infusion over 46-48 hours, on day 1; Bevacizumab: 5 mg/kg, intravenous infusion, on day 1. Repeat every 2 weeks.