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The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | All patients of this arm are treated by TACE together with Andostatin. |
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| 2 | Active Comparator | All patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Arterial Chemoembolization | Procedure | The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, Mortality | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival | 2 years |
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Inclusion Criteria:
Haematopoietic:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-Hui Chen, MD | Contact | +86 25 83272121 | noriko0706@sohu.com | |
| Gang Deng, MD, Ph.D | Contact | +86 25 83272118 | dmm1996@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, MD, Ph.D | Zhongda Hospital, Southeast University, Nanjing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Interventional Radiology, Zhongda Hospital, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
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| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |