Comparing two treatments for intermediate-stage liver cancer
Official title: 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)
Run by Zhejiang Raygene Pharmaceuticals Co., Ltd · NCT06844357 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Zhejiang Raygene Pharmaceuticals Co., Ltd Industry-sponsored |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Status | Recruiting |
| Started | March 27, 2025 |
| Main results expected | April 1, 2029 |
| Study ends | April 1, 2029 |
| Registry record updated | April 6, 2025 |
| Trial ID | NCT06844357 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with primary hepatocellular carcinoma who are eligible for TAE or TACE treatment.
✕Probably not a fit
Patients with a history of liver transplantation or those with severe cardiovascular or renal diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using embolization techniques for liver cancer, but the specific approach of TATE is relatively novel.
Who can join: the full rules
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 it's running
-
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
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.