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)

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06844357

Enrollment

300

Registered

2025-02-25

Start date

2025-03-27

Completion date

2029-04-01

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival (PFS)	36 months	Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.

Secondary

Measure	Time frame	Description
Complete Response (CR) rate	36 months	Complete response rate (CR) assessed by IRC using mRECIST criteria
objective response rate (ORR)	36 months	—
duration of complete response (DOCR)	36 months	—
overall survival (OS)	36 months	—

Countries

China

Contacts

Primary ContactBill Shen, Ph.D.

bill.shen@raygene.cn057185131875

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026