Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere

Phase 3

Recruiting

• Conditions: Unresectable Hepatocellular Carcinoma
• Interventions: Drug: NRT6003 Injection; Drug: cTACE

• Registration Number: NCT06900543
• Lead Sponsor: Chengdu New Radiomedicine Technology Co. LTD.

Brief 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.

Study Timeline

• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-21
• Study First Posted: 2025-03-28
• Study Start: 2025-04-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-10
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NRT6003 Injection	NRT6003 Injection	Selective internal radiation therapy (SIRT) with TareSphere
cTACE	cTACE	Transarterial chemoembolization

Primary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	Through study completion, at least 18 months	Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria

Secondary Outcome Measures

Name	Time	Method
Localized Time to Progression	Through study completion, at least 18 months	Evaluated by the investigator in accordance with the mRECIST criteria
Objective Response Rate	Through study completion, at least 18 months	Evaluated by the investigator in accordance with the mRECIST criteria
Duration of Response	Through study completion, at least 18 months	Evaluated by the investigator in accordance with the mRECIST criteria
Surgery Rate	From the administration to study completion, at least 18 months	Resection rate of liver target lesions
Overall Survival (OS)	From the administration to study completion, at least 18 months	Based on survival follow-up information
Changes in Tumor Biomarkers	From the administration to study completion, at least 18 months	The variation of alpha fetoprotein (AFP) levels
Incidence and severity of adverse events (AE) and severe adverse events (SAE)	Throughout the study, at least 18 months	In accordance with NCI-CTCAE 5.0
Objective Response Rate (ORR)	Through study completion, at least 18 months	Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Duration of Response (DOR)	Through study completion, at least 18 months	Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Localized Time to Progression (localized TTP)	Through study completion, at least 18 months	Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Time to Progression	Through study completion, at least 18 months	Evaluated by the investigator in accordance with the mRECIST criteria

Trial Locations

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

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