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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.

Phase 3RecruitingSun Yat-sen UniversityNCT06201065Data as of May 2026

Treatment: Lenvatinib · Toripalimab · oxaliplatin , fluorouracil, and leucovorinOur 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

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

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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

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

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