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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TATE | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tirapazamine | Drug | Intra-arterial injection into the tumor feeding artery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) rate | Complete response rate (CR) assessed by IRC using mRECIST criteria | 36 months |
| objective response rate (ORR) | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bill Shen, Ph.D. | Contact | 057185131875 | bill.shen@raygene.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gaojun Teng, M.D | Zhongda Hospital | Principal Investigator |
| Jiansong Ji, M.D | The Central Hospital of Lishui City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
Privacy Protection for Participants
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| Transarterial Embolization (TAE) |
| Procedure |
Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia |
|
| TACE | Procedure | TACE with epirubicin |
|
| duration of complete response (DOCR) | 36 months |
| overall survival (OS) | 36 months |
| Lishui Central Hospital | Recruiting | Lishui | Zhejiang | 323000 | China |
|
| ID | Term |
|---|---|
| D000077704 | Tirapazamine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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