Actively Recruiting
Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer
Led by Fudan University · Updated on 2025-02-27
36
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Confirmed colorectal adenocarcinoma with RAS wild type or BRAF V600E mutation by PCR or NGS
- Failure or intolerance of standard first-line treatment (including oxaliplatin and/or irinotecan with fluorouracil for MSS; immunotherapy for MSI-H BRAF V600E mutated patients)
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 to 2
- Adequate bone marrow and organ function: neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L, white blood cells ≥3.0×10⁹/L, albumin ≥32 g/L, no bleeding tendency; AST, ALT, ALP ≤2.5×ULN (≤5×ULN if liver metastases), total bilirubin ≤1.5×ULN; serum creatinine ≤1.5×ULN or creatinine clearance ≥60 ml/min
- Expected survival of at least 3 months
- Able to understand the study and provide informed consent
You will not qualify if you...
- Previous treatment with BRAF inhibitors or irinotecan liposomes
- Known allergy to study drugs or their ingredients
- Symptomatic, untreated brain or meningeal metastases without clinical stability
- Acute or subacute intestinal obstruction or chronic inflammatory bowel disease
- Other malignancies within the past 5 years except cured cervical carcinoma in situ, uterine carcinoma in situ, or non-melanoma skin cancer
- Pregnant or breastfeeding women or those refusing contraception if of childbearing potential
- Investigator considers the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Wenhua Li, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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