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OncoMatch/Clinical Trials/NCT05608213

Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC

Is NCT05608213 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Lenvatinib for hepatocellular carcinoma non-resectable.

Phase 3RecruitingSecond Affiliated Hospital of Guangzhou Medical UniversityNCT05608213Data as of May 2026

Treatment: LenvatinibThis study is conducted to evaluate the efficacy and safety of lenvatinib plus iodine-125 seed brachytherapy (Len-I) compared with lenvatinib (Len) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 0 prior lines

Cannot have received: systemic therapy

Patients who received prior systemic therapy ... for HCC

Cannot have received: immunotherapy

Patients who received prior ... immunotherapy ... for HCC

Cannot have received: hepatic arterial infusion chemotherapy

Patients who received prior ... hepatic arterial infusion chemotherapy (HAIC) ... for HCC

Cannot have received: radiation therapy

Patients who received prior ... radiotherapy for HCC

Lab requirements

Blood counts

platelets <50×10^9/L [excluded]; prothrombin time prolongation ≥ 4s [excluded]

Liver function

Child-Pugh class A/B

Cardiac function

Severe organ (heart, lung, kidney) dysfunction [excluded]

Child-Pugh class A/B; Hematologic examination: platelets <50×10^9/L; Prothrombin time prolongation ≥ 4s; Severe organ (heart, lung, kidney) dysfunction

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

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