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

Summary

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).

Eligibility

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 \<50×10\^9/L
* Prothrombin time prolongation ≥ 4s
* Severe organ (heart, lung, kidney) dysfunction
* History of malignancy other than HCC

Conditions4

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