Back to resultsA Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
Primary Purpose
Intrahepatic Cholangiocarcinoma, Second-line Treatment
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
- Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment;
- The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
- Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
- Life expectancy of at least 12 weeks;
- Subjects who understand and voluntarily signed a written informed consent form.
Exclusion Criteria:
- Previous locoregional therapy within 4 weeks prior to enrollment.
- Diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
- History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma.
- Prepared for liver transplantation.
- Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).
- A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
- Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment.
- Patients with central nervous system metastases or brain metastasis
- Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia.
- Pregnant or lactating women.
- Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apatinib
Arm Description
A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Secondary Outcome Measures
Overall Survival (OS)
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
Full Information
NCT ID
NCT03251443
First Posted
August 14, 2017
Last Updated
November 30, 2020
Sponsor
Peking Union Medical College Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03251443
Brief Title
A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
Official Title
Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
May 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma, Second-line Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apatinib
Arm Type
Experimental
Arm Description
A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Other Intervention Name(s)
Apatinib mesylate tablets
Intervention Description
500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
Time Frame
six months
Title
Objective Response Rate (ORR)
Time Frame
one year
Title
Disease Control Rate (DCR)
Time Frame
one year
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause
Time Frame
two years
Title
Incidence of Treatment-Emergent Adverse Event
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment;
The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
Life expectancy of at least 12 weeks;
Subjects who understand and voluntarily signed a written informed consent form.
Exclusion Criteria:
Previous locoregional therapy within 4 weeks prior to enrollment.
Diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma.
Prepared for liver transplantation.
Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).
A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment.
Patients with central nervous system metastases or brain metastasis
Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia.
Pregnant or lactating women.
Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hai-tao Zhao
Organizational Affiliation
Peking Union Medical College Hospital (PUMCH)
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
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