Evaluate the Effect of Tirazamine on Primary Liver Cancer.

Last updated: February 24, 2025
Sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd
Overall Status: Terminated

Phase

1/2

Condition

Carcinoma

Treatment

Transarterial Embolization

tirapazamine

TACE

Clinical Study ID

NCT06848556
LT005
  • Ages 18-80
  • All Genders

Study Summary

This Phase I/II trial aims to evaluate the pharmacokinetics, efficacy, and safety of tirapazamine administered via hepatic artery injection followed by TACE in patients with intermediate-stage HCC. The trial will compare the outcomes of TATE with standard TACE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hepatocellular carcinoma, either histologically/cytologically confirmed orclinically diagnosed

  • Age 18-80 years

  • Patient is eligible to do TAE or TACE treatment.

  • ECOG performance status score 0-1.

  • Child-Pugh score 5 - 7 .

  • No portal vein tumor thrombus, lymph node metastasis, peritoneal tumor seeding, orextrahepatic metastasis.

Exclusion

Exclusion Criteria:

  • Prior liver transplantation

  • History of liver tumor embolization or radioembolization

  • Uncontrolled HBV or HCV infection

  • Significant cardiovascular, pulmonary, or renal disease

  • QTc prolongation or use of QTc-prolonging medications

Study Design

Total Participants: 16
Treatment Group(s): 3
Primary Treatment: Transarterial Embolization
Phase: 1/2
Study Start date:
May 14, 2021
Estimated Completion Date:
November 20, 2023

Study Description

The clinical trial is bifurcated into two distinct strata.

Phase One:

This stratum is designed to elucidate the pharmacokinetics of Tirapazamine, specifically its concentration in peripheral blood, in patients with hepatocellular carcinoma (HCC) subsequent to hepatic arterial infusion of Tirapazamine at dosages of 5, 10, and 20 mg/m², culminating in hepatic arterial embolization. A total of approximately 12 patients are slated for enrollment, with 3 to 6 patients allocated to each dosage tier. This constitutes a multicenter, open-label, dose-escalation study. Initiation occurs at a Tirapazamine dosage of 5 mg/m² (administered to 3 patients), followed by escalation to 10 mg/m² (administered to 3 patients), and culminating at 20 mg/m² (administered to 6 patients). All subjects undergo hepatic arterial infusion of Tirapazamine directed towards the tumor vasculature, followed by embolization utilizing a formulation comprising iodized oil, gelatin sponge, and contrast agent (the preparation and application of the embolic agent are delineated in Appendix E).

Phase Two:

Phase Two is delineated as a Phase II open-label, randomized, controlled trial that compares the therapeutic outcomes of TATE (Transarterial Tirapazamine Embolization) and TACE (Transarterial Chemoembolization) in patients with intermediate-stage primary hepatocellular carcinoma who are candidates for hepatic arterial embolization. This phase may be conducted contemporaneously with Phase One. Approximately 200 patients will be randomized in a 1:1 ratio to either the experimental arm (Group A, TATE ) or the control arm (Group B, TACE ). Inter-arm crossover is proscribed.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Site Not Available

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