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OncoMatch/Clinical Trials/NCT06492395

Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT

Is NCT06492395 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Len+DEB-TACE+HAIC and Len+DEB-TACE for hepatocellular carcinoma non-resectable.

Phase 3RecruitingSecond Affiliated Hospital of Guangzhou Medical UniversityNCT06492395Data as of May 2026

Treatment: Len+DEB-TACE+HAIC · Len+DEB-TACEThis study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+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: TACE

previous treatment with TACE

Cannot have received: HAIC

previous treatment with HAIC

Cannot have received: TAE

previous treatment with TAE

Cannot have received: radiotherapy

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, prothrombin time prolongation >4 s [excluded]

Kidney function

creatinine clearance rate ≤1.5× upper limit of the normal

Liver function

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

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 s [excluded]; 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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