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A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSMs-TACE+ Surgical Resection Group | Experimental | After TACE using Lobaplatin and GSMs (150-350μm, 350-560μm, 560-710μm or 710-1000μm), patients will receive surgical resection 15-30 days later, as specified per protocol. |
|
| Surgical Resection Group | Active Comparator | Patients will receive surgical resection, as specified per protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSMs-TACE | Device | TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival(DFS) | 6 months | |
| Median Overall Survival (mOS) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intrahepatic Metastasis | 6 months | |
| Incidence of Extrahepatic Metastasis | 1 and 2 years | |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuewei Zhang | Contact | 00861800115669 | zhangyuewei1121@sina.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | China |
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|
| Surgical Resection | Procedure | Surgical Resection of HCC |
|
|
| 1 and 2 years |
| Adverse Events | 6 months |
| ID | Term |
|---|---|
| D006498 | Hepatectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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