NCT06900543

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Chengdu New Radiomedicine Technology Co. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 when receiving NRT6003 Injection compared to cTACE? Investigators will compare NRT6003 Injection to cTACE to determine: 1. Whether NRT6003 Injection demonstrates superior efficacy in tumor control and long-term survival (e.g., objective response rate, time to progression, etc.). 2. Whether NRT6003 Injection has a comparable or improved safety profile vs. cTACE (e.g., incidence of adverse events, etc.). Participants will: 1. Receive either NRT6003 Injection or cTACE as per randomized assignment. 2. Undergo scheduled follow-up visits for imaging assessments (e.g., MRI or CT scans, etc.) and safety evaluations. 3. Provide blood samples for biomarker analysis. 4. Report any symptoms or medical events through a patient diary and during clinic visits.

Conditions

• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	NRT6003 Injection	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.
DRUG	cTACE	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.

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-03-28
• Last updated: 2025-05-20

Locations

11 sites across 1 country: China