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

Last updated: April 2, 2025
Sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Transarterial Embolization (TAE)

tirapazamine

TACE

Clinical Study ID

NCT06844357
RG001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with primary hepatocellular carcinoma according to AASLDcriteria.

  • No evidence of extrahepatic metastasis, regional lymph node involvement, or vasculartumor 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

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 oxygensupplementation)

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Transarterial Embolization (TAE)
Phase: 2/3
Study Start date:
March 27, 2025
Estimated Completion Date:
April 01, 2029

Connect with a study center

  • Zhongda Hospital, Affiliated to Southeast University

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

  • Lishui Central Hospital

    Lishui, Zhejiang 323000
    China

    Active - Recruiting

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