Trial | NCT02702323  Report issue

Official Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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 Started
Mar 31
2016
Primary Completion
Mar 31
2018
Anticipated
Study Completion
Mar 31
2019
Anticipated
Last Update
Mar 08
2016
Estimate

Drug Apatinib

apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE

Procedure TACE

one times every 4-6 weeks.

  • Other names: transcatheter arterial chemoembolization

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.

Criteria 

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)
No Results Posted