Hepatocellular Carcinoma, Pulmonary Metastasis
Conditions
Keywords
hepatocellular carcinoma, pulmonary metastasis, Apatinib, efficacy, safety
Brief summary
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
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.
Interventions
DRUGApatinib
apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE
PROCEDURETACE
one times every 4-6 weeks.
Sponsors
First Affiliated Hospital of Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
The Central Hospital of Lishui City
First Affiliated Hospital of Wenzhou Medical University
Ningbo No.2 Hospital
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progress Free Survival | 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. | PFS is defined as the months that from the anticipation of the clinical-trial to the progress of hepatocellular cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 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. | OS is defined as the months that from the anticipation of the clinical-trial to the death of patients. |
| Objective response rate | 1 month post intervention | Time to progress of lung lesions which was confirmed by CT/MRI |
| The Quality of Life | 0 to 24 months post intervention | — |
| Toxicity as measured by CTCAE V4.0 | 0 to 24 months post intervention | — |
Contacts
Primary Contactguoliang shao, phD
Backup Contactliwen guo, MD
Outcome results
None listed