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

Phase 2

Recruiting

• Conditions: HCC
• Interventions: Drug: tirapazamine; Procedure: TACE; Procedure: Transarterial Embolization (TAE)

• Registration Number: NCT06844357
• Lead Sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-25
• Study Start: 2025-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2029-04-01
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TATE	tirapazamine	Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.
TATE	Transarterial Embolization (TAE)	Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.
TACE	TACE	Patients will receive cTACE with a mixture of iodized oil （10mL）and epirubicin (50 mg ), followed by embolization with gelatin sponge and contrast agent suspension.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Zhongda Hospital, Affiliated to Southeast University; 🇨🇳 Nanjing, Jiangsu, China

Lishui Central Hospital; 🇨🇳 Lishui, Zhejiang, China