In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators conducted the dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Now we are going to start a phase 2 trial with apatinib 500mg + POF as first-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
Rongbo Lin
Fuzhou, Fujian, China
Objective response rate
According to RECIST 1.1
Time frame: From enrollment to 3 months after treatment
Progression-free survival
The length of time from enrollment until the time of progression of disease
Time frame: From enrollment to progression of disease. Estimated about 12 months.
Overall survival
The length of time from enrollment until the time of death
Time frame: From enrollment to death of patients. Estimated about 18 months
Toxicity According to NCI CTCAE 4.03 criteria
According to NCI CTCAE 4.03 criteria
Time frame: From enrollment to 3 months after treatment
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