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Clinical Trials in China / NCT06844357
Recruiting Phase 2/3

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

NCT06844357 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang Raygene Pharmaceuticals Co., Ltd
Phase
Phase 2/3
Started
2025-03-27
Last updated
2025-04-06

Condition(s) studied

HCC

Investigational drug(s) / intervention(s)

tirapazamine →Transarterial Embolization (TAE)TACE

tirapazamine: Intra-arterial injection into the tumor feeding artery

Transarterial Embolization (TAE): Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia

TACE: TACE with epirubicin

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Progression-free survival (PFS) — 36 months
    Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.

Trial sites (2)

FacilityCityRegionStatus
Zhongda Hospital, Affiliated to Southeast University Nanjing Jiangsu Recruiting
Lishui Central Hospital Lishui Zhejiang Recruiting

Other trials for the same condition

Predictive Value of Minimal Residual Disease for Postoperative Recurrence and Adjuvant PD-1 Inhibitor in HCC Starting soon
Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy Starting soon
A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk Recruiting
Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma Recruiting
Composite Warming Strategy Reduces Intraoperative Hypothermia in Open Hepatectomy for Liver Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06844357 on ClinicalTrials.gov ↗ ← All trials in China