OncoMatch/Clinical Trials/NCT05408221

the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib in Hepatocellular Carcinoma

Is NCT05408221 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Rulonilimab+Lenvatinib for hepatocellular carcinoma.

Phase 2/3RecruitingShandong New Time Pharmaceutical Co., LTDNCT05408221Data as of May 2026

Treatment: Rulonilimab+Lenvatinib — There are two studies included in this protocol. One is an open-label Phase Ⅱ study . The other is a multi-center, double-blind, randomized, phase III study .

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: systemic chemotherapy

Subjects have not received any systemic therapy for HCC previously (mainly including systemic chemotherapy, anti-angiogenic drugs or other molecular targeted therapy, antibodies/drugs targeting T cell co-regulatory proteins (such as anti-CTLA-4, anti-PD-1 /PD-L1, anti-OX-40, anti-CD137, anti-TIM-3, anti-LAG-3 antibodies, etc.)

Lab requirements

Blood counts

neutrophil count (ANC) ≥1.5×10^9/L, hemoglobin (HGB) ≥90g/L, platelet count (PLT) ≥75×10^9/L

Kidney function

serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min

Liver function

Child-Pugh score A or B (≤7); Total bilirubin ≤2×ULN, ALT and AST≤5×ULN; serum albumin ≥29g/L

Cardiac function

LVEF (left ventricular ejection fraction) < 50% [excluded]; QTc interval ≥480ms [excluded]

Child-Pugh score A or B (≤7); Blood test: neutrophil count (ANC) ≥1.5×10^9/L, hemoglobin (HGB) ≥90g/L, platelet count (PLT) ≥75×10^9/L; liver function: Total bilirubin ≤2×ULN, ALT and AST≤5×ULN; kidney function: serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min; serum albumin ≥29g/L; LVEF (left ventricular ejection fraction) < 50% [excluded]; QTc interval ≥480ms [excluded]

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

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