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OncoMatch/Clinical Trials/NCT06184698

Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

Is NCT06184698 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including liposomal irinotecan and 5-FU for colorectal cancer.

Phase 2RecruitingHebei Medical University Fourth HospitalNCT06184698Data as of May 2026

Treatment: liposomal irinotecan · 5-FU · LV · BevacizumabThis is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy (oxaliplatin) — first-line

First-line treatment with oxaliplatin-based therapy

Cannot have received: topoisomerase inhibitor (irinotecan, liposomal irinotecan)

Previous treatment with irinotecan/liposomal irinotecan

Cannot have received: antineoplastic therapy

Patients who had received any intravenous antineoplastic therapy within 28 days or oral antineoplastic therapy within 14 days before the first dose of study drug

Lab requirements

Blood counts

ANC ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L, WBC≥3.0×10^9/L

Kidney function

serum creatinine ≤1.5 x ULN or creatinine clearance ≥60 mL/min, proteinuria <2+

Liver function

total bilirubin ≤1.5 × ULN, AST, ALP and ALT ≤2.5 x ULN, ≤5 x ULN if liver metastases are present

adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin (Hgb) ≥90 g/L, white blood cell (WBC)≥3.0×10^9/L. Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present. Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL/min, proteinuria <2+.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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