Clinical trial Recruiting at 2 sites Phase2; Phase3 Interventional Ages 18 and up

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

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorZhejiang Raygene Pharmaceuticals Co., Ltd
Industry-sponsored
Locations2 sites (Nanjing, Jiangsu and 1 other locations)
StatusRecruiting
StartedMarch 27, 2025
Main results expectedApril 1, 2029
Study endsApril 1, 2029
Registry record updatedApril 6, 2025
Trial IDNCT06844357 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.