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

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.