A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT03251443|
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic Cholangiocarcinoma Second-line Treatment||Drug: Apatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma|
|Actual Study Start Date :||August 8, 2017|
|Actual Primary Completion Date :||March 8, 2019|
|Actual Study Completion Date :||May 8, 2019|
A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.
500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Other Name: Apatinib mesylate tablets
- Progression-free Survival (PFS) [ Time Frame: six months ]A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
- Objective Response Rate (ORR) [ Time Frame: one year ]
- Disease Control Rate (DCR) [ Time Frame: one year ]
- Overall Survival (OS) [ Time Frame: two years ]Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause
- Incidence of Treatment-Emergent Adverse Event [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251443
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100730|
|Study Chair:||Hai-tao Zhao||Peking Union Medical College Hospital (PUMCH)|