Lenvatinib Plus Iodine-125 Seed Brachytherapy Compared With Lenvatinib Alone for TACE-refractory Hepatocellular Carcinoma: a Single Center, Prospective, Randomized Control Trail
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Mingyue Cai, MD
cai020@yeah.net
+86-20-34156205
Backup
Kangshun Zhu, MD
zhksh010@163.com
+86-20-34156205
Time Frame
Start Date: 2022-11-02
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 187
Treatments
Experimental: Len-I
Active_comparator: Len
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University