OncoMatch/Clinical Trials/NCT06201065
FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial
Is NCT06201065 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Lenvatinib and Toripalimab for hepatocellular carcinoma.
Treatment: Lenvatinib · Toripalimab · oxaliplatin , fluorouracil, and leucovorin — Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count (ANC) >1,500/mm3
Kidney function
Serum creatinine ≤ 1.5 x upper limit of normal
Liver function
Total bilirubin ≤ 30mmol/L; Serum albumin ≥ 30 g/L; ASL and AST ≤ 5 x upper limit of normal; INR ≤ 1.5 or PT/APTT within normal limits
Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
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