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

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 gourp
    Irinotecan 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

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