Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere

The main questions it aims to answer are:

• Does NRT6003 Injection improve tumor response rates compared to cTACE in patients with unresectable HCC?
• What adverse events do participants experience when receiving NRT6003 Injection compared to cTACE?

Investigators will compare NRT6003 Injection to cTACE to determine:

• Whether NRT6003 Injection demonstrates superior efficacy in tumor control and long-term survival (e.g., objective response rate, time to progression, etc.).
• Whether NRT6003 Injection has a comparable or improved safety profile vs. cTACE (e.g., incidence of adverse events, etc.).

Participants will:

• Receive either NRT6003 Injection or cTACE as per randomized assignment.
• Undergo scheduled follow-up visits for imaging assessments (e.g., MRI or CT scans, etc.) and safety evaluations.
• Provide blood samples for biomarker analysis.
• Report any symptoms or medical events through a patient diary and during clinic visits.

Key Inclusion Criteria:

• 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 Criteria:

• 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.