A Randomized, Open-label, Multicenter Study Comparing the Efficacy and Safety of NRT6003 Injection With Conventional Transarterial Chemoembolization (cTACE) in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial is to evaluate the efficacy and safety of NRT6003 Injection compared to cTACE in patients with unresectable HCC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosed as hepatocellular carcinoma (CNLC Ⅰa-Ⅲa) clinically, by imaging and/or pathology based on the guideline of the National Health Commission of the People's Republic of China (2024).
• Evaluated by the investigator as not suitable for surgical resection/ablation/liver transplantation, or there is high risk for surgical resection, or the participant refuses surgical resection/ablation/liver transplantation.
• Child-Pugh score ≤ 7.
• Eastern Cooperative Oncology Group performance status ≤ 1.
• Adequate organ function.
Locations
Other Locations
China
West China Hospital
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Mengchao Hepatobiliary Hospital of Fujian Medical University
RECRUITING
Fuzhou
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The First Hospital of China Medical University
RECRUITING
Shenyang
Tianjin Cancer Hospital Airport Hospital
RECRUITING
Tianjin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Gaojun Teng
zdyyjgb@163.com
+8602583272084
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 108
Treatments
Experimental: NRT6003 Injection
Selective internal radiation therapy (SIRT) with TareSphere
Active_comparator: cTACE
Transarterial chemoembolization
Related Therapeutic Areas
Sponsors
Leads: Chengdu New Radiomedicine Technology Co. LTD.