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

April 2, 2025 updated by: Zhejiang Raygene Pharmaceuticals Co., Ltd

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital, Affiliated to Southeast University
        • Contact:
    • Zhejiang
      • Lishui, Zhejiang, China, 323000
        • Recruiting
        • Lishui Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TATE
Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.
Drug: tirapazamine
Intra-arterial injection into the tumor feeding artery
Procedure: Transarterial Embolization (TAE)
Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
Experimental: TACE
Patients will receive cTACE with a mixture of iodized oil （10mL）and epirubicin (50 mg ), followed by embolization with gelatin sponge and contrast agent suspension.
Procedure: TACE
TACE with epirubicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 36 months
Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR) rate
Time Frame: 36 months
Complete response rate (CR) assessed by IRC using mRECIST criteria
36 months
objective response rate (ORR)
Time Frame: 36 months
36 months
duration of complete response (DOCR)
Time Frame: 36 months
36 months
overall survival (OS)
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Raygene Pharmaceuticals Co., Ltd

Investigators

  • Principal Investigator: Gaojun Teng, M.D, Zhongda Hospital
  • Principal Investigator: Jiansong Ji, M.D, The Central Hospital of Lishui City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2025

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Privacy Protection for Participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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