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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

Len+DEB-TACE+HAICLen+DEB-TACE

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06492395 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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