clinical study of apatinib and 5-fu combination regimen to treat advanced colorectal cancer patients

Conditions: Metastatic Colorectal Cancer

Summary: this study makes an observation over the objective response rate of apatinib and 5-fu combination regimen in the three-line treatment of metastatic colorectal cancer. all the participants will randomly receive the treatment of apatinib and 5-fu combination regimen or 5-fu.

5-fu chemotherapy is an effective therapy for colorectal cancer. apatinib is a small-molecule tyrosine kinase inhibitor (tki) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (vegfr-2), with a decrease in vegf-mediated endothelial cell migration, proliferation, and tumor microvascular density. a phase ii trail of apatinib has been demonstrated that apatinib is safe to treat the metastatic colorectal cancer and the disease control rate can reach 50%.

Eligibility criteria:
inclusion criteria: * 18 and ≤ 70 years of age * histological confirmed advanced or metastatic colorectal cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral ct scan(scanning layer ≤ 5 mm ) * have failed for ≥ 2 lines of chemotherapy * life expectancy of more than 3 months * ecog performance scale ≤ 1 * duration from the last therapy is more than 6 weeks for nitroso or mitomycin more than 4 weeks for operation, radiotherapy or cytotoxic agents * adequate hepatic, renal, heart, and hematologic functions (platelets \> 80 × 10e+9/l, neutrophil \> 1.5 × 10e+9/l, serum creatinine ≤ 1×upper limit of normal(uln), bilirubin \< 1.25 uln, and serum transaminase ≤ 2.5× 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: * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * pregnant or lactating women * 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 * before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * any factors that influence the usage of oral administration evidence of cns metastasis * urt: urine protein ≥ (++)and \> 1.0 g of 24 h * pt, aptt, tt, fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation * abuse of drugs * certain possibility of gastric or intestine hemorrhage * less than 4 weeks from the last clinical trial * viral hepatitis type b or type c * prior vegfr inhibitor treatment * evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

Keywords: apatinib