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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.

Phase 2RecruitingFudan UniversityNCT06763029Data as of May 2026

Treatment: Irinotecan liposomes combined with cetuximab + vermofenibEfficacy 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.

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Extracted 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

Min 1 prior line

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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