RecruitingPhase 2NCT06763029

Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer

Phase II Exploratory Study of Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced RAS Wild /BRAF Mutated Colorectal Cancer


Sponsor

Fudan University

Enrollment

36 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Efficacy and safety of irinotecan liposomes combined with cetuximab + vermofenib in first-line failure of advanced RAS wild /BRAF mutated colorectal cancer, Exploratory analysis of biomarkers (including but not limited to ctDNA, immune microenvironment indicators, tumor mutation load, lymphocyte subsets, cytokines, gut microbes, and others) in relation to efficacy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — irinotecan liposomes, cetuximab, and vemurafenib — as second-line treatment for advanced colorectal cancer. The combination is designed specifically for tumors with a BRAF V600E mutation or RAS wild-type status that have progressed after first-line chemotherapy. **You may be eligible if...** - You are 18 or older - You have colorectal cancer confirmed by biopsy with either RAS wild-type or BRAF V600E mutation - Your cancer has progressed after or you could not tolerate standard first-line treatment - You have at least one measurable tumor on imaging - You are in good general health (ECOG 0–2) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have not tried first-line standard chemotherapy - Your blood counts or organ function do not meet study requirements - Your cancer has specific genetic profiles not covered by this treatment combination 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.

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Interventions

DRUGIrinotecan liposomes combined with cetuximab + vermofenib

Vermofenil 960mg orally twice daily; Irinotecan liposomes, 70mg/m2, d1, 90 min intravenously, Q2W; Cetuximab 500mg/m2, d1, Q2W;


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06763029


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