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

Recruiting now · Phase 3

Conditions studied: Hepatocellular Carcinoma Non-resectable

In brief

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).

Key facts

Study ID

NCT05608213

Run by

Second Affiliated Hospital of Guangzhou Medical University

People needed

187

Starts

2022-11-02

Expected to finish

2026-12-01

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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