A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.
NCT ID: NCT06844357
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2025-03-27
2029-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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.
TACE
TACE with epirubicin
Interventions
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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
Eligibility Criteria
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Inclusion 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
* Previous radioemblization or radiotherapy for liver tumors.
* severe cardiovascular or renal diseases, active systemic infections.
* Clinically significant hypoxia (oxygen saturation \< 92% without oxygen supplementation)
18 Years
ALL
No
Sponsors
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Zhejiang Raygene Pharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Gaojun Teng, M.D
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Jiansong Ji, M.D
Role: PRINCIPAL_INVESTIGATOR
The Central Hospital of Lishui City
Locations
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Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China
Lishui Central Hospital
Lishui, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RG001
Identifier Type: -
Identifier Source: org_study_id
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