Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere
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)
Chengdu New Radiomedicine Technology Co. LTD.
108 participants
Apr 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria4
- 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.
Interventions
Patients will be administered NRT6003 Injection via Intra-arterial infusion, and subsequently they will be assessed by PET/CT imaging within 24 hours for its distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.
Patients will receive cTACE treatment. And the investigators will select one or more chemotherapy drugs in combination with embolic materials for administration, based on the specific condition of the patient.
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06900543