Advanced Cancer Clinical Trial
Official title:
A Randomized,Parallel Controlled,Multicentre,Phase II Study of Apatinib Plus POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) Versus POF in Patients With Advanced/Metastatic Bastric Cancer
This study is a randomized, parallel control, multicenter,phase II study, comparing the efficacy and safety of apatinib plus POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) versus POF, in the first-line treatment for patients with advanced/metastatic gastric cancer.
This is a randomized, two-arm, open-label, multicenter phase II trial. Our primary purpose is
to compare that PFS rate at 6-month of patients with apatinib plus POF and POF for
advanced/metastatic gastric cancer.
Eligible patients will randomized to a ratio of 1:1 to apatinib+POF (experimental group) or
POF (control group). Stratification factors were 1) gender (male;female);2) previous surgical
history (yes;no);3) metastatic sites (measurable; Immeasurable).
In treatment period, patients will be administrated POF, with or without apatinib, every 14
days for 1 cycle, total 9-12 cycles.After the above treatment finished,parients will received
with S-1,with or without apatinib,every 21days for 1 cycle,until disease progression,
toxicity intolerance, withdrawal of informed consent, patients judged must be terminated
study termination.
The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.
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