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NCT Number: NCT06844357

A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.

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.

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Key information

Conditions

HCC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Zhongda Hospital, Affiliated to Southeast University, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tirapazamine

Drug

Intra-arterial injection into the tumor feeding artery

Transarterial Embolization (TAE)

Procedure

Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia

TACE

Procedure

TACE with epirubicin

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 36 months

    Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.

Secondary outcomes

  1. Complete Response (CR) rate

    Time frame: 36 months

    Complete response rate (CR) assessed by IRC using mRECIST criteria

  2. objective response rate (ORR)

    Time frame: 36 months

  3. duration of complete response (DOCR)

    Time frame: 36 months

  4. overall survival (OS)

    Time frame: 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Bill Shen, Ph.D.

CONTACT

[email protected]

057185131875

Sponsors and collaborators

Lead sponsor

Zhejiang Raygene Pharmaceuticals Co., Ltd

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 25, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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