Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere

Launched by CHENGDU NEW RADIOMEDICINE TECHNOLOGY CO. LTD. · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called NRT6003 Injection to see how safe and effective it is for patients with unresectable hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be removed through surgery. The trial will compare this new treatment to a standard procedure called cTACE, which helps to block blood flow to the tumor. The goal is to find out which option works better for patients who are not able to have surgery or other common treatments.

To participate in this trial, patients need to be between the ages of 65 to 74 and have been diagnosed with HCC that cannot be surgically treated. They should also have a specific score that indicates their liver function is stable and should be feeling well enough to engage in daily activities. However, individuals who have cancer that has spread beyond the liver or who have received previous cancer treatments will not be eligible. This trial is not yet recruiting participants, but it offers an opportunity for those who meet the criteria to explore a new potential treatment for their condition.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. 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).
• • 2. 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.
• • 3. Child-Pugh score ≤ 7.
• • 4. Eastern Cooperative Oncology Group performance status ≤ 1.
• • 5. Adequate organ function.
• Key Exclusion Criteria:
• • 1. Imaging evidence or suspicion of extrahepatic metastases (including regional lymph node metastases).
• • 2. Prior antitumor treatment for primary hepatocellular carcinoma.
• • 3. Prior external radiation therapy or intra-arterial brachytherapy.
• • 4. Liver vascular evaluation results that do not meet all the requirements of the study.