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A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE Combined with Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) with Type III Portal Vein Tumor Thrombus (PVTT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSMs-TACE+ Surgical Resection Group | Experimental | After TACE using epirubicin and GSMs (150-350μm or 350-560μm), patients that meet certain criteria will receive surgical resection of PVTT, as specified per protocol. |
|
| GSMs-TACE Group | Active Comparator | Patients will receive TACE using epirubicin and GSMs (150-350μm or 350-560μm), as specified per protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSMs-TACE | Device | TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | PFS is defined as the time from Day 1 of treatment until the progression of a target lesion or the appearance of new lesions. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (mOS) | 2 years | |
| Overall Survival | 3, 6, 12 and 18 months | |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuewei Zhang | Contact | 00861800115669 | zhangyuewei1121@sina.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yuewei Zhang | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Changgung Hospital | Recruiting | Beijing | China |
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|
| Surgical Resection | Procedure | Surgical Resection of PVTT |
|
| 6 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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