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

• Status: Not yet recruiting
• Trial end date: 2021-12-25
• Target enrollment: 0
• Participant gender: All

Summary

It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Guangxi Medical University
• Treatments: Apatinib; Capecitabine

Criteria

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.