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Recruiting NCT06844357

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

Phase II / Phase III Interventional HCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tirapazamine, Transarterial Embolization (TAE), TACE.
Who it may be relevant to
Registry conditions: HCC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • 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
  • Procedure TACE
    TACE with epirubicin

Primary outcome measures

  • Progression-free survival (PFS) [Time frame: 36 months]
Secondary outcome measures (4)
  • Complete Response (CR) rate [Time frame: 36 months]
  • objective response rate (ORR) [Time frame: 36 months]
  • duration of complete response (DOCR) [Time frame: 36 months]
  • overall survival (OS) [Time frame: 36 months]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Zhongda Hospital, Affiliated to Southeast University — Nanjing
  • Lishui Central Hospital — Lishui

Identifiers

NCT: NCT06844357 · RG001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗