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

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

Lenvatinib Plus Iodine-125 Seed Brachytherapy Compared With Lenvatinib Alone for TACE-refractory Hepatocellular Carcinoma: a Single Center, Prospective, Randomized Control Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608213
• Other study ID #: MIIR-11
• Status: Recruiting
• Phase: Phase 3
• Start date: November 2, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Mingyue Cai, MD
• Phone: +86-20-34156205
• Email: cai020[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 187
• Est. completion date: December 1, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Intervention

Procedure:
• Lenvatinib Plus I-125 Seed Brachytherapy
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.

Drug:
• Lenvatinib
Lenvatinib (body weight = 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be administered to the patients.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	The time from date of randomization to death due to any cause.	4 years
Secondary	Progression free survival (PFS)	The time from date of randomization until the first occurrence of disease progression (according to mRECIST) or death due to any cause, whichever occurs first.	4 years
Secondary	Time to Progression (TTP)	The time from date of randomization until the first occurrence of disease progression (according to mRECIST).	4 years
Secondary	Objective response rate (ORR)	The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.	4 years
Secondary	Disease control rate (DCR)	The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.	4 years
Secondary	Adverse Events (AEs)	Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.	4 years