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| Name | Class |
|---|---|
| CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD | UNKNOWN |
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The goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional TACE (Transarterial Chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres.
The main questions it aims to answer are:
Researchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTACE | Placebo Comparator |
| |
| cTACE with magnesium microspheres | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Microspheres | Device | Biodegradable Magnesium Embolic Microspheres |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The objective response rate of the target lesion | 30 days after the last TACE treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of embolization technique for the target lesion | Success rate of embolization technique for the target lesion | on the day of the surgery |
| DCR | Disease control rate of the target lesion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuntao G PM | Contact | 86+0512 6938 6599 | ctgong@innobm.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | China | |||
| Anyang Tumor Hospital |
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| cTACE | Procedure | cTACE |
|
| 30 days after the first TACE treatment |
| CR | Complete Response of the target lesion | 30 days after the first TACE treatment |
| ORR | Objective Response Rate of the target lesion | 90 days after the last TACE treatment |
| Anyang |
| Henan |
| China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | China |
| Lishui Central Hospital | Lishui | Zhejiang | China |
| The Third Affiliated Hospital,Sun Yat-Sen University | Guangzhou | China |
| The First Hospital of Lanzhou University | Lanzhou | China |
| The First Affiliated Hospital of Henan University of Science & Technology | Luoyang | China |
| Fudan University Shanghai Cancer Center | Shanghai | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | China |