A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma

This is an interventional treatment trial for Biliary Carcinoma focused on measuring Biliary cancer, adjuvant therapy, apatinib, capecitabine Read More

Inclusion Criteria:

• Fully aware of the research and voluntarily signed informed consent (informed consent must be signed prior to the execution of any required test procedure);
• Patients received removal of biliary tract cancers that have been confirmed by histology or cytology, including intrahepatic bile duct carcinoma (IHCC), extrahepatic bile duct cancer (EHCC), and gallbladder cancer(GBC);
• Normal function of major organs that meets the following criteria:

Blood routine examination:

HB≥90 g/L； ANC≥1.5×109/L； PLT≥60×109/L；

Biochemical examination:

ALB ≥29 g/L； ALT and AST<2.5ULN； TBIL ≤2ULN； Creatinine≤1.5ULN;

• ECOG physical condition scores 0 or 1;
• Fertile male or female patients volunteer to use effective contraception methods during the research period, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc.
• Fertile and non-lactational female who show negative in serum or urine pregnancy test within 7 days before inclusion for the study.

Exclusion Criteria:

• Those who received approved or on-going anti-tumor therapy within 4 weeks before the research;
• Those who received other anti-angiogenic tyrosine kinase inhibitors or monoclonal antibodies that had been approved or under study before the research;
• Abnormal laboratory tests that have significant clinical implication;
• International normalized ratio (INR) ≥ 1.5 or partially activated prothrombin time (APTT) ≥ 1.5 × ULN;
• The patient's current serum potassium, serum magnesium, or serum calcium is below the normal reference range of laboratory test (whether supplemented or not), or >CTCAE grade 1;
• Patients currently suffering from hypertension that cannot be controlled with drugs;
• The researchers conclude electrolyte abnormalities that are clinically significant;
• There is severe bleeding or hemoptysis in the past or at current stage, or there are thromboembolic events within 12 months;
• Cardiovascular diseases that are clinically significant;
• ECG showed QTcB interval ≥ 480 milliseconds in resting state;
• Suffering from other malignant tumors in the past 5 years, excluding basal cell carcinoma or squamous cell carcinoma after receiving radical surgery, or carcinoma in situ of cervix;
• Active or uncontrollable serious infection (≥ CTCAE grade 2 infection), including but not limited to human immunodeficiency virus (HIV) infection;
• Known history of liver disease with evident significance;
• The patient currently has brain metastasis or spinal compression, except individual cases.