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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
Apatinib Mesylate Tablets 500 mg qd po
5-Fluorouracil 400mg/m2 iv d1,2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).
Hui ting Xu
Wuhan, Hubei, China
RECRUITINGORR
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Time frame: From assignment of the first subject to 3 months later after the last participant is recruited.
DCR
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)
Time frame: From assignment of the first subject to 3 months later after the last participant is recruited.
PFS
PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
Time frame: From assignment of the first subject to 3 months later after the last participant is recruited.
OS
OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: From assignment of the first subject until 30 death events observed, up to 2 years.
QoL
The general well-being of participants, outlining negative and positive features of life.
Time frame: From assignment of the first subject to 3 months later after the last participant is recruited.
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