Clinical Trial: Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancer

Brief Summary: This study is designed to see whether Apatinib is effective in treating patients with advanced refractory biliary tract cancers.

Detailed Summary:

Biliary tract cancers (BTC) includes cholangiocarcinoma and gallbladder carcinoma (GBC). The systematic treatment based on gemcitabine plus cisplatin is recommended as the current standard chemotherapy for unresectable or metastatic BTC. There is no standard recommendation for second line therapy.

Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2).

This study was conducted to assess the efficacy and safety of Apatinib in patients with advanced refractory BTC who had received first-line chemotherapy.


Sponsor: Sun Yat-sen University

Current Primary Outcome: Progression-free survival (PFS) [ Time Frame: Approximately 1 year ]

the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival (OS) [ Time Frame: Approximately 2 years ]
    Defined as the time from randomize to death
  • Disease control rate(DCR) [ Time Frame: Approximately 1 year ]
    Defined as the rate of complete response , partial response and stable disease according to RECIST guidelines
  • Quality of life(QoL) [ Time Frame: Approximately 1 year ]
    As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
  • Safety (incidence of adverse events) [ Time Frame: Approximately 1 year ]
    Incidence of adverse events


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: May 5, 2017
Date Started: February 22, 2017
Date Completion: March 1, 2019
Last Updated: May 8, 2017
Last Verified: May 2017