NCT06844357RecruitingPhase 2/3
A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE 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)
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This phase I/II clinical trial aims to determine the efficacy and safety of TATE compared to TACE in patients with intermediate-stage HCC. The results will provide valuable insights into the potential benefits of TATE as a novel treatment option for HCC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 27 Mar 2025
- Primary completion date
- 1 Apr 2029
- Lead sponsor
- Zhejiang Raygene Pharmaceuticals Co., Ltd
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06844357
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 300
- From 27 Mar 2025 to the primary completion date, 1 Apr 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radioemblization or radiotherapy for liver tumors.
Other illness
- History of liver transplantation.
- severe cardiovascular or renal diseases, active systemic infections.
Other
- Clinically significant hypoxia (oxygen saturation \< 92% without oxygen supplementation)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lishui Central Hospital Coordinator of this site? Confirm its status | Lishui | China | Recruiting |
| Zhongda Hospital Affiliated to Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.