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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| The Central Hospital of Lishui City | OTHER |
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This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other half will receive TACE therapy alone.
Apatinib is a VEGFR targeting tyrosine kinase inhibitor, which has preliminary demonstrated the efficacy and safety in treatment of advanced hepatocellular carcinoma by phase II stage research. Pulmonary metastasis of hepatocellular cancer is one of the difficulties in clinical practice,because it's not sensitive to systemic chemotherapy.This phase â…¢ study aims to evaluates the efficacy and safety of the Apatinib in the treatment of advanced hepatocellular cancer with pulmonary metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib & TACE | Experimental | Apatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks. |
|
| TACE | Active Comparator | TACE therapy one times every 4-6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival | PFS is defined as the months that from the anticipation of the clinical-trial to the progress of hepatocellular cancer | Change from Baseline mRECIST at 12 months was assessed every 4 weeks up to 48 weeks. Data collection is from date of randomization until the date of first documented progression assessed up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | OS is defined as the months that from the anticipation of the clinical-trial to the death of patients. | Survival assessed every 4 weeks up to 24 months following objective disease progression. Data collection is from date of randomization until the date of death from any cause, assessed up to 48 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| guoliang shao, phD | Contact | +86 13958183472 | shaoguoliang2008@126.com | |
| liwen guo, MD | Contact | +86 18329130398 | guoliwen2008@126.com |
| Name | Affiliation | Role |
|---|---|---|
| guoliang shao, phD | Zhejiang Cancer 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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| ID | Term |
|---|---|
| C553458 | apatinib |
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| First Affiliated Hospital of Wenzhou Medical University |
| OTHER |
| Ningbo No.2 Hospital | OTHER |
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| TACE |
| Procedure |
one times every 4-6 weeks. |
|
|
| Objective response rate |
Time to progress of lung lesions which was confirmed by CT/MRI |
| 1 month post intervention |
| The Quality of Life | 0 to 24 months post intervention |
| Toxicity as measured by CTCAE V4.0 | 0 to 24 months post intervention |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |