Apatinib in the Treatment of Metastatic Colorectal Cancer

A Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed After Standard Second Line Therapy

This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.

Inclusion Criteria:

• ≥ 18 and ≤ 80 years of age
• Histological confirmed advanced or metastatic colorectal cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT
• Have failed for ≥ 2 lines of chemotherapy and/or targeted therapy
• Life expectancy of more than 3 months
• ECOG performance scale 0～1
• Duration from the last therapy is more than 4 weeks for operation, radiotherapy or cytotoxic agents
• Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 ×10^9/L, neutrophil > 1.5 × 10^9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.5 ULN, and serum transaminase ≤ 2.0× ULN)
• Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
• Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

• Prior VEGFR inhibitor treatment within 2 weeks
• History of other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy
• More than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
• Pregnant or lactating women
• Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• URT: urine protein ≥ (++)and > 1.0 g of 24 h
• PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
• Certain possibility of gastric or intestine hemorrhage