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

RecruitingPhase 3Ages 18 Years - 75 YearsAllSecond Affiliated Hospital of Guangzhou Medical Uโ€ฆ
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In plain words

What the trial is, and whether it could suit you

This 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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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * HCC confirmed by histopathology and/or cytology, or diagnosed clinically * Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021) * Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included * At least one measurable intrahepatic target lesion * Child-Pugh class A/B * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months Exclusion Criteria: * Extrahepatic metastasis * Tumor thrombus involving main portal vein or both the first left and right branch of portal vein * Vena cava invasion * Patients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCC * History of organ and cell transplantation * History of bleeding from esophagogastric varices * History of hepatic encephalopathy * Hematologic examination: platelets \<50ร—10\^9/L * Prothrombin time prolongation โ‰ฅ 4s * Severe organ (heart, lung, kidney) dysfunction * History of malignancy other than HCC
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What it tests

  • Lenvatinib Plus I-125 Seed Brachytherapy
  • Lenvatinib
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Where

1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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