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Evaluate the Effect of Tirazamine on Primary Liver Cancer.

NCT06848556 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-02-27

No results posted yet for this 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.

Conditions

  • Hepato Cellular Carcinoma (HCC)

Interventions

DRUG

tirapazamine

Intra-arterial injection into the tumor feeding artery

PROCEDURE

Transarterial Embolization

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

PROCEDURE

TACE

Patients received standard Transarterial Chemoembolization (TACE) with intra-arterial injection of a mixture of epirubicin and iodized oil at a personalized dose, followed by embolization completed by injecting a suspension of gelatin sponge and contrast agent.

Sponsors & Collaborators

  • Zhejiang Raygene Pharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Caifang Ni, M.D · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2023-11-06
Completion
2023-11-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06848556 on ClinicalTrials.gov