OncoMatch/Clinical Trials/NCT06341296
Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer
Is NCT06341296 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Irinotecan Liposome and 5-FU for metastatic colorectal cancer.
Treatment: Irinotecan Liposome · 5-FU · LV · Bevacizumab — To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: KRAS mutation
RAS/BRAF v600e mutant or right half colon cancer is known.
Allowed: NRAS mutation
RAS/BRAF v600e mutant or right half colon cancer is known.
Allowed: BRAF V600E
RAS/BRAF v600e mutant or right half colon cancer is known.
Allowed: MLH1 proficient mismatch repair
pMMR/MSS is known.
Allowed: MSH2 proficient mismatch repair
pMMR/MSS is known.
Allowed: MSH6 proficient mismatch repair
pMMR/MSS is known.
Allowed: PMS2 proficient mismatch repair
pMMR/MSS is known.
Disease stage
Required: Stage IV
Metastatic disease required
The unresectable stage of metastatic disease has not received any systemic antitumor therapy. The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: irinotecan (irinotecan, irinotecan liposomes)
Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
Cannot have received: VEGF inhibitor (bevacizumab)
Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
Lab requirements
Blood counts
Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10^9/L, and no bleeding tendency
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min (Cockroft-Gault)
Liver function
AST, ALT and alkaline phosphatase (ALP) ≤2.5× ULN, and ≤5×ULN when liver metastases occurred; total bilirubin ≤ ULN
Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10^9/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; The total bilirubin level doesn't exceed the upper limit of the agency's normal range; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40 ml/min (calculated according to Cockroft-Gault)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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