RecruitingPhase 2Phase 3NCT06844357

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

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)


Sponsor

Zhejiang Raygene Pharmaceuticals Co., Ltd

Enrollment

300 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two procedures for treating intermediate-stage liver cancer (hepatocellular carcinoma): a standard procedure called conventional TACE (which cuts off blood supply to the tumor using particles and chemotherapy drugs), versus a newer approach called TATE (which uses a drug called tirapazamine that specifically kills cancer cells in low-oxygen environments, delivered directly through the blood vessels feeding the tumor). **You may be eligible if...** - You have been diagnosed with primary liver cancer (hepatocellular carcinoma) - Your cancer has not spread outside the liver or into blood vessels - You are eligible for the TACE or TATE liver-directed procedure - You are in reasonably good health and your liver is functioning adequately **You may NOT be eligible if...** - You have had a previous liver transplant - You have previously received radiation to the liver - You have severe heart, kidney, or other organ disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtirapazamine

Intra-arterial injection into the tumor feeding artery

PROCEDURETransarterial Embolization (TAE)

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

PROCEDURETACE

TACE with epirubicin


Locations(2)

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, China

Lishui Central Hospital

Lishui, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06844357


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