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 Ⅲ study aims to evaluates the efficacy and safety of the Apatinib in the treatment of advanced hepatocellular cancer with pulmonary metastasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Progress Free Survival
PFS is defined as the months that from the anticipation of the clinical-trial to the progress of hepatocellular cancer
Time frame: 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.
overall survival
OS is defined as the months that from the anticipation of the clinical-trial to the death of patients.
Time frame: 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
Time frame: 1 month post intervention
The Quality of Life
Time frame: 0 to 24 months post intervention
Toxicity as measured by CTCAE V4.0
Time frame: 0 to 24 months post intervention
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