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
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Lishui Central Hospital
RECRUITING
Lishui
Zhongda Hospital, Affiliated to Southeast University
RECRUITING
Nanjing
Contact Information
Primary
Bill Shen, Ph.D.
bill.shen@raygene.cn
057185131875
Time Frame
Start Date: 2025-03-27
Estimated Completion Date: 2029-04-01
Participants
Target number of participants: 300
Treatments
Experimental: TATE
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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Raygene Pharmaceuticals Co., Ltd