This study makes an observation over the objective response rate of Apatinib and XELOX combination regimen in the first-line treatment of metastatic colorectal cancer. All the participants will receive the treatment of Apatinib and XELOX combination regimen.
XELOX chemotherapy is an effective therapy for metastatic colorectal cancer as first-line treatment. 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%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Apatinib Mesylate Tablets 500 mg P.O.d1-21 and XELOX (oxaliplatin 130mg/㎡ i.v. d1, capecitabine 1000mg P.O. d1-d14) Every 3-week time is a cycle until PD or intolerance of drug toxicity occurs.
Cancer Cnter,The First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGObjective Response Rate (ORR)
ORR=complete response (CR) + partial response (PR) .And expected ORR is 0.55.
Time frame: up to 9 months
Progression-free Survival (PFS)
time from randomization to documented progressive disease or death due to any cause, whichever occurs first
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
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