A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

Sponsor
Peking Union Medical College Hospital
Study ID
NCT03251443
Phase
PHASE2
Status
Completed

Conditions

  • Intrahepatic Cholangiocarcinoma
  • Second-line Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.

Study Details

The purpose of this study is to explore the efficacy and safety of second-line treatment of apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety, progression free and overall survival. The primary endpoint of this study is objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).

Key Dates

Start date
Aug 8, 2017
Status verified
Jul 2019
Primary completion
Mar 8, 2019
Completion
May 8, 2019

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib
    A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: six months ]

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