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

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

NCT ID: NCT05608213

Condition: Hepatocellular Carcinoma Non-resectable

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib

Conditions: Keywords:
Hepatocellular Carcinoma
Lenvatinib
iodion-125 seed

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Lenvatinib Plus I-125 Seed Brachytherapy
Description: Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be administered to the patients. Iodion-125 seeds will be implanted into the the target lesions (viable intrahepatic tumor and/or vascular tumor thrombus) under CT guidance according to the pre-operative planning within 7 days after lenvatinib administration. Iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
Arm group label: Len-I

Intervention type: Drug
Intervention name: Lenvatinib
Description: Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be administered to the patients.
Arm group label: Len

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).

Detailed description: This is a single-center, prospective and randomized controlled trial to evaluate the efficacy and safety of Len-I versus Len alone for patients with TACE-refractory HCC. 187 patients with TACE-refractory HCC will be enrolled in this study. The patients will receive either Len-I or Len alone using an 2:1 randomization scheme. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the Len-I arm, iodion-125 seeds will be implanted into the the target lesions (viable intrahepatic tumor and/or vascular tumor thrombus) under CT guidance according to the pre-operative planning within 7 days after lenvatinib administration. Iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. The primary end point of this study is overall survival (OS). The secondary endpoints are progression-free survival (PFS), time to progression (TTP), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Second Affiliated Hospital of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510260
Country: China

Status: Recruiting

Contact:
Last name: Kangshun Zhu, MD

Phone: +86-20-34156205
Email: zhksh010@126.com

Start date: November 2, 2022

Completion date: December 1, 2026

Lead sponsor:
Agency: Second Affiliated Hospital of Guangzhou Medical University
Agency class: Other

Source: Second Affiliated Hospital of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05608213