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

Study Overview
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Brief Summary
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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).

Official Title
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Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

Conditions
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Intrahepatic Cholangiocarcinoma, Second-line Treatment

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib<br>A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor. | Drug: Apatinib<br>* 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.<br>* Other names: Apatinib mesylate tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death. | six months | 
| Objective Response Rate (ORR) |  | one year | 
| Disease Control Rate (DCR) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | two years | 
| Incidence of Treatment-Emergent Adverse Event |  | one year |