Actively Recruiting
A Randomized, Open-label, Multicenter Study Comparing the Efficacy and Safety of NRT6003 Injection With Conventional Transarterial Chemoembolization in Chinese Patients With Unresectable Hepatocellular Carcinoma
Led by Chengdu New Radiomedicine Technology Co. LTD. · Updated on 2025-05-20
108
Participants Needed
11
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on patients with unresectable hepatocellular carcinoma (HCC). Researchers are studying the effects of NRT6003 Injection compared to conventional transarterial chemoembolization (cTACE) to determine which treatment better controls tumors and impacts long-term survival. The trial also evaluates the safety profiles of both treatments by monitoring adverse events experienced by participants. Participants are randomly assigned to receive either NRT6003 Injection through intra-arterial infusion or cTACE, where chemotherapy drugs and embolic materials are selected based on patient condition. After treatment, NRT6003 patients undergo PET/CT imaging within 24 hours to assess drug distribution. The study includes scheduled follow-ups with imaging assessments like MRI or CT scans and safety evaluations. During the study, participants provide blood samples for biomarker analysis and report symptoms or medical events via patient diaries and clinic visits. The primary outcome is time to progression, measured for at least 18 months. Secondary outcomes include objective response rate, duration of response, surgery rate, overall survival, changes in tumor biomarkers, and monitoring of adverse events throughout the study period.
CONDITIONS
Brief Title
Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hepatocellular carcinoma (CNLC a-a) by clinical, imaging, or pathology methods according to Chinese guidelines
- Not suitable for or refusing surgical resection, ablation, or liver transplantation, or at high surgical risk
- Child-Pugh liver function score of 7 or less
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ function as determined by the investigator
You will not qualify if you...
- Evidence or suspicion of cancer spread outside the liver, including regional lymph nodes
- Prior antitumor treatment for primary hepatocellular carcinoma
- Previous external radiation therapy or intra-arterial brachytherapy
- Liver vascular evaluation not meeting study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months or until disease progression or discontinuation
Participants receive either NRT6003 Injection via intra-arterial infusion or conventional transarterial chemoembolization (cTACE) as per randomized assignment.
1 treatment visit and scheduled follow-up visits for imaging assessments and safety evaluations
Duration - Through study completion, at least 18 months
Participants undergo scheduled follow-up visits for imaging assessments, safety evaluations, blood sample collection for biomarker analysis, and report symptoms or medical events through patient diaries and clinic visits.
Regular follow-up visits during treatment period
Trial Site Locations
Total: 11 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
3
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
4
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
5
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
7
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
8
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
9
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
10
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
11
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
G
Gaojun Teng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here