OncoMatch/Clinical Trials/NCT06763029
Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer
Is NCT06763029 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Irinotecan liposomes combined with cetuximab + vermofenib for colorectal cancer metastatic.
Treatment: Irinotecan liposomes combined with cetuximab + vermofenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
RAS wild
Required: NRAS wild-type
RAS wild
Allowed: BRAF V600E
BRAF V600E mutation was detected by PCR or NGS
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard first-line treatment (oxaliplatin, irinotecan, fluorouracil) — first-line
Failure or intolerance of standard first-line treatment. First-line regimens including oxaliplatin and/or irinotecan in combination with fluorouracil in patients with MSS
Must have received: anti-PD-1 therapy — first-line
For BRAF V600E mutated patients with MSI-H, first-line immunotherapy with PD-1 or PD-L1 is required
Must have received: anti-PD-L1 therapy — first-line
For BRAF V600E mutated patients with MSI-H, first-line immunotherapy with PD-1 or PD-L1 is required
Cannot have received: BRAF inhibitor
Patients who have previously received BRAF inhibitors
Cannot have received: irinotecan liposomes
Patients who have previously received...irinotecan liposomes
Lab requirements
Blood counts
Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×10^9/L, albumin (ALB) ≥32 g/L, and no bleeding tendency
Kidney function
Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (Cockroft-Gault)
Liver function
AST, ALT and alkaline phosphatase (ALP) ≤2.5× ULN, and ≤5×ULN when liver metastases occurred; Total bilirubin ≤1.5×ULN
Good bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×109/L, albumin (ALB) ≥32 g/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; Total bilirubin ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated according to Cockroft-Gault);
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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