Evaluating NRT6003 Injection for Unresectable Liver Cancer
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)
This study is testing a new injection called NRT6003 to see if it works better and is safer than the standard treatment for people with liver cancer that can't be surgically removed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chengdu New Radiomedicine Technology Co. LTD. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 11 sites (Fuzhou, Fujian and 10 other locations) |
| Trial ID | NCT06900543 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of NRT6003 Injection compared to conventional Transarterial Chemoembolization (cTACE) in patients with unresectable hepatocellular carcinoma (HCC). Participants will be randomly assigned to receive either NRT6003 Injection or cTACE, followed by scheduled follow-up visits for imaging assessments and safety evaluations. The study will measure tumor response rates and adverse events to determine if NRT6003 Injection offers superior efficacy and a comparable or improved safety profile. Blood samples will also be collected for biomarker analysis.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with unresectable hepatocellular carcinoma who are not suitable for surgical resection or have refused such options.
Not a fit: Patients with evidence of extrahepatic metastases or those who have previously undergone antitumor treatments for HCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for managing unresectable liver cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches in treating liver cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Fuzhou, Fujian and 10 other locations
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
- Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
- Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)
- The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
- Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Gaojun Teng — Zhongda Hospital
- Study coordinator: Gaojun Teng
- Email: zdyyjgb@163.com
- Phone: +8602583272084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.