Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer
- Sponsor
- Fudan University
- Study ID
- NCT06763029
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Colorectal Cancer Metastatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Irinotecan liposomes combined with cetuximab + vermofenib — DRUGVermofenil 960mg orally twice daily; Irinotecan liposomes, 70mg/m2, d1, 90 min intravenously, Q2W; Cetuximab 500mg/m2, d1, Q2W;
Study Details
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.
Key Dates
- Start date
- Feb 26, 2025
- Status verified
- Feb 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Irinotecan liposome gourpIrinotecan liposomes combined with cetuximab + vermofenib
Primary Outcome Measure
Objective response rate [ Time Frame: The evaluation period was up to 24 months from the date the participant entered the clinical study and started the medication ]
Central Contacts
- Wenhua Li, Ph.D+86 18017317210
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