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This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC
Microwave ablation (MWA) is available as the major curative treatments for early-stage recurrent HCC. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated MWA simultaneously combined Lenvatinib for recurrent HCC. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this randomized, multicenter, prospective trial study to find out it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave ablation | Experimental | Patients only accepted microwave ablation |
|
| Microwave ablation plus lenvatinib | Experimental | Patients accepted microwave ablation plus lenvatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave ablation | Procedure | only microwave ablation for tumor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor-free survival rate at 36 months | Progression was defined as progressive disease after microwave ablation by independent radiologic review according to mRECIST or death from any cause | 36 months |
| Over-all survival (OS) rate at 36 months | OS is the length of time from the date of microwave ablation until death from any cause. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report. | 24 months |
| Complication rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunfnag Zhou, MD | Contact | 86 19868000115 | zhouqun988509@163.com | |
| Xiaohui Wang, MD | Contact | 8615692436948 | xiaohuiwang21@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianhai Mao, Professor | Hunan Provincial People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| Lenvatinib | Drug | lenvatinib (80 mg for body no more than 60kg,120 mg for body weight >60 kg) |
|
Complication was defined as the a disease or sythrome caused by the therapy
| 36 months |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |