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

Zhejiang Raygene Pharmaceuticals Co., Ltd

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: HCC

Treatments: Procedure: Transarterial Embolization (TAE); Procedure: TACE; Drug: tirapazamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06844357

RG001

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

TATE

Experimental group

Description:

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.

Treatment:

Drug: tirapazamine

Procedure: Transarterial Embolization (TAE)

TACE

Experimental group

Description:

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.

Treatment:

Procedure: TACE