Status:
RECRUITING
Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere
Lead Sponsor:
Chengdu New Radiomedicine Technology Co. LTD.
Conditions:
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
The main questions it aims to answer are: 1. Does NRT6003 Injection improve tumor response rates compared to cTACE in patients with unresectable HCC? 2. What adverse events do participants experience...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- Imaging evidence or suspicion of extrahepatic metastases (including regional lymph node metastases).
- Prior antitumor treatment for primary hepatocellular carcinoma.
- Prior external radiation therapy or intra-arterial brachytherapy.
- Liver vascular evaluation results that do not meet all the requirements of the study.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06900543
Start Date
April 15 2025
End Date
December 1 2027
Last Update
May 20 2025
Active Locations (11)
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1
Fujian Cancer Hospital
Fuzhou, Fujian, China
2
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
3
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
4
Henan Cancer Hospital
Zhengzhou, Henan, China