Clinical trial NCT06900543: Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Unresectable Hepatocellular Carcinoma
Keywords: Selective internal radiation therapy
Yttrium-90
Transarterial Radioembolization
Conventional Transarterial Chemoembolization
Lead sponsor: Chengdu New Radiomedicine Technology Co. LTD.
Sponsor class: INDUSTRY
First posted: 2025-03-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to Progression (TTP)
timeFrame: Through study completion, at least 18 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Through study completion, at least 18 months
measure: Duration of Response (DOR)
timeFrame: Through study completion, at least 18 months
measure: Localized Time to Progression (localized TTP)
timeFrame: Through study completion, at least 18 months
measure: Time to Progression
timeFrame: Through study completion, at least 18 months
measure: Localized Time to Progression
timeFrame: Through study completion, at least 18 months
measure: Objective Response Rate
timeFrame: Through study completion, at least 18 months
measure: Duration of Response
timeFrame: Through study completion, at least 18 months
measure: Surgery Rate
timeFrame: From the administration to study completion, at least 18 months
measure: Overall Survival (OS)
timeFrame: From the administration to study completion, at least 18 months
measure: Changes in Tumor Biomarkers
timeFrame: From the administration to study completion, at least 18 months
measure: Incidence and severity of adverse events (AE) and severe adverse events (SAE)
timeFrame: Throughout the study, at least 18 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital Airport Hospital
state: Tianjin
Study officials:
affiliation: Zhongda Hospital
name: Gaojun Teng
role: PRINCIPAL_INVESTIGATOR
References: