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OncoMatch/Clinical Trials/NCT06904183

Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT

Is NCT06904183 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including LEN+SIN+DEB-TACE+HAIC and LEN+SIN+DEB-TACE for hepatocellular carcinoma non-resectable.

Phase 2RecruitingSecond Affiliated Hospital of Guangzhou Medical UniversityNCT06904183Data as of May 2026

Treatment: LEN+SIN+DEB-TACE+HAIC · LEN+SIN+DEB-TACEThis study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).

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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: transarterial chemoembolization

previous treatment with TACE

Cannot have received: hepatic arterial infusion chemotherapy

previous treatment with HAIC

Cannot have received: transarterial embolization

previous treatment with TAE

Cannot have received: radiation therapy

previous treatment with radiotherapy

Cannot have received: systemic therapy

previous treatment with systemic therapy

Lab requirements

Blood counts

leukocyte count >3.0×10^9/L, neutrophil count >1.5×10^9/L, platelet count ≥75×10^9/L, hemoglobin 85 g/L

Kidney function

creatinine clearance rate ≤1.5×upper limit of the normal

Liver function

alanine transaminase and aspartate transaminase ≤5×upper limit of the normal; prothrombin time prolongation ≤4 seconds; Child-Pugh class A/B

Cardiac function

organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment [excluded]

adequate hematologic and organ function, with leukocyte count>3.0×10^9/L, neutrophil count>1.5×10^9/L, platelet count≥75×10^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds; Child-Pugh class A/B; organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment [excluded]

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

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