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The study has gotten preliminary results and stopped advanced.
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| Name | Class |
|---|---|
| Shulan (Hangzhou) Hospital | OTHER |
| West China Hospital | OTHER |
| Huashan Hospital | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University |
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To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Recurrence of HCC is still a great challenge and threat to the patients after resection surgery. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. HCC patients who meet the eligibility criteria of this clinical trial will be administrated Anlotinib 12mg QD PO d1-14, 21 days per cycle. The disease free survival (DFS), overall survival (OS) and any adverse effect during the 8 cycles of Anlotinib treatment will be evaluated in order to assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Hydrochloride | Drug | Anlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | The period from resection surgery to recurrence of HCC | From randomization to recurrence of HCC or death (up to 1year) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect | Any adverse effects occur during the use of anlotinib | Up to 1year |
| Overall survival | The survival rate in a year | 1 year |
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Inclusion Criteria:
A. portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Medical School of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The First Hospital of Jilin University | OTHER |
| Tianjin First Central Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |