Comparing two treatments for intermediate-stage liver cancer
A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)
This study is testing if a new treatment called TATE is better and safer than the standard treatment cTACE for people with intermediate-stage liver cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang Raygene Pharmaceuticals Co., Ltd Industry-sponsored |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06844357 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of Transarterial Tirapazamine Embolization (TATE) compared to conventional Transarterial Chemoembolization (cTACE) in patients with intermediate-stage hepatocellular carcinoma (HCC). The study will enroll patients who meet specific eligibility criteria, including those with no evidence of extrahepatic metastasis and adequate organ function. By comparing these two treatment approaches, the trial seeks to provide insights into the potential advantages of TATE as a novel therapeutic option for HCC.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with primary hepatocellular carcinoma who are eligible for TAE or TACE treatment.
Not a fit: Patients with a history of liver transplantation or those with severe cardiovascular or renal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new and effective treatment option for patients with intermediate-stage liver cancer.
How similar studies have performed: Other studies have shown promise in using embolization techniques for liver cancer, but the specific approach of TATE is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria. * No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus. * Patients must be eligible for TAE or TACE treatment. * ECOG ≤ 1. * Child-Pugh score ≤ 7. * Adequate bone marrow, liver, and kidney function is required. Exclusion Criteria: * History of liver transplantation. * Previous radioemblization or radiotherapy for liver tumors. * severe cardiovascular or renal diseases, active systemic infections. * Clinically significant hypoxia (oxygen saturation \< 92% without oxygen supplementation)
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- Zhongda Hospital, Affiliated to Southeast University — Nanjing, Jiangsu, China (Recruiting)
- Lishui Central Hospital — Lishui, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Gaojun Teng, M.D — Zhongda Hospital
- Study coordinator: Bill Shen, Ph.D.
- Email: bill.shen@raygene.cn
- Phone: 057185131875
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.