Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere (CHEERS)

Chengdu New Radiomedicine Technology

Status and phase: Enrolling; Phase 3

Conditions: Unresectable Hepatocellular Carcinoma

Treatments: Drug: cTACE; Drug: NRT6003 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06900543

CTR20250792 (Other Identifier)

NRT6003-HCC-2024

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the efficacy and safety of NRT6003 Injection compared to cTACE in patients with unresectable HCC.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

NRT6003 Injection

Experimental group

Description:

Selective internal radiation therapy (SIRT) with TareSphere

Treatment:

Drug: NRT6003 Injection

cTACE

Active Comparator group

Description:

Transarterial chemoembolization

Treatment:

Drug: cTACE