Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Ⅲ study aims to evaluates the efficacy and safety of the Apatinib in the treatment of advanced hepatocellular cancer with pulmonary metastasis.

Official Title
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Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

Conditions
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Hepatocellular Carcinoma, Pulmonary Metastasis

Intervention / Treatment
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* Drug: Apatinib
* Procedure: TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of hepatocellular carcinoma refused to sorafenib treatment have at least one measurable pulmonary lesions expected survival time ≥ 12 weeks Exclusion Criteria: within four weeks before the study received radiotherapy or chemotherapy With a variety of factors influencing oral drugs taking and absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib & TACE<br>Apatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks. | Drug: Apatinib<br>* apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE<br>Procedure: TACE<br>* one times every 4-6 weeks.<br>* Other names: transcatheter arterial chemoembolization;|
| Active Comparator: TACE<br>TACE therapy one times every 4-6 weeks. | Procedure: TACE<br>* one times every 4-6 weeks.<br>* Other names: transcatheter arterial chemoembolization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, hepatocellular carcinoma, pulmonary metastasis, Apatinib, safety