Status:
COMPLETED
A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Intrahepatic Cholangiocarcinoma
Second-line Treatment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03251443
Start Date
August 8 2017
End Date
May 8 2019
Last Update
December 2 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730