OncoMatch/Clinical Trials/NCT06225622
Dose Escalation and Expansion Clinical Trial of Irinotecan Liposome Combined With Oxaliplatin and 5-FU/LV Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer
Is NCT06225622 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for metastatic colorectal cancer.
Treatment: Irinotecan Liposome · Oxaliplatin · 5-FU · LV · Bevacizumab · Cetuximab — Dose escalation clinical trial: To explore the dose limiting toxicity (DLT) of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab in first-line treatment of patients with advanced metastatic colorectal cancer, and to estimate the maximum tolerated dose (MTD) of combined administration. Expansion clinical trial: To evaluate the safety and efficacy of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab or cetuximab in first-line treatment of patients with advanced metastatic colorectal cancer. Exploratory analysis of ctDNA changes and genetic mutations in patients at baseline.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
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 0–0(Fully active)
Prior therapy
Cannot have received: irinotecan
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) ≥35 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) all ≤2.5× ULN, and ≤5×ULN when liver metastases occurred; total bilirubin level doesn't exceed the upper limit of the agency's normal range
Normal bone marrow and organ function: ① 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) ≥35 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; 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 ≥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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