RecruitingPhase 3NCT06900543

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)


Sponsor

Chengdu New Radiomedicine Technology Co. LTD.

Enrollment

108 participants

Start Date

Apr 15, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of TareSphere, a type of liver-targeted radiation therapy (radioembolization using tiny radioactive beads), in patients with liver cancer (hepatocellular carcinoma) in China. **You may be eligible if...** - You have been diagnosed with hepatocellular carcinoma (liver cancer) - Surgery, ablation, or liver transplant is not suitable for you or you have refused it - Your liver function is relatively preserved (Child-Pugh score of 7 or less) - Your overall physical condition is good to moderate (ECOG score of 0 or 1) - Your key organ functions (blood, liver, kidneys) meet required levels **You may NOT be eligible if...** - Imaging suggests cancer has spread outside the liver (including to lymph nodes) - You have already received treatment for your liver cancer - You have had prior external radiation or internal liver radiation therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNRT6003 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.

DRUGcTACE

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)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

West China Hospital

Chengdu, Sichuan, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06900543


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