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The aim of this study is to evaluate the efficacy and safety of lenvatinib in the treatment of recurrence of hepatocellular carcinoma after liver transplantation.
The research is an open, one-arm, single-center study. 40 patients with recurrence of hepatocellular carcinoma after liver transplantation are included according to the criteria of admission. The enrolled patients are treated with lenvatinib (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day). The baseline data of patients are collected before allocation. Serum and imaging examination are checked regularly every month to monitor the recurrence of hepatocellular carcinoma and the side effects of lenvatinib. The efficacy and safety of lenvatinib in the treatment of recurrence of hepatocellular carcinoma are observed, and the clinicopathological factors affecting the efficacy of lenvatinib are analyzed. When side effects of lenvatinib occur, the dosage can be reduced according to the patients' condition until discontinuation. When tumor advances, a multidisciplinary team will draw up specific treatment plans according to the patients' condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| relenvatinib | Experimental | The enrolled patients are treated with lenvatinib (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| relenvatinib | Drug | The enrolled patients are treated with lenvatinib (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 years recurrence-free survival rate | Tumor recurrence within 3 years | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year recurrence-free survival rate | Tumor recurrence within 1 year | 1 year |
| 5 years recurrence-free survival rate | Tumor recurrence within 5 years |
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Inclusion Criteria:
12.The participants have the capability of oral medication. 13.The participants must sign the consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qiang Xia, doctor | Contact | +8613661889035 | xiaqiang1966@126.com |
| Name | Affiliation | Role |
|---|---|---|
| qiang xia, doctor | RenJi Hospital | Study Chair |
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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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The cases are from patients with recurrent hepatocellular carcinoma who underwent liver transplantation in the liver surgery department of Shanghai Renji Hospital. The enrolled patients are treated with lenvatinib (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day).
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| 5 years |
| 1 year overall survival rate | overall survival with one year | 1 year |
| 3 years overall survival rate | overall survival with 35 years | 3 years |
| 5 years overall survival rate | overall survival with 5 years | 5 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |