A Phase 2 interventional study of Apatinib and POF in Gastric Adenocarcinoma, sponsored by Fujian Cancer Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-10.
Sponsored by Fujian Cancer Hospital · Phase 2, Interventional, and Treatment
In previous studies,the investigators 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 the investigators are going to start a phase 2 trial with apatinib 500mg + POF as second-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 26 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Fujian Cancer Hospital is the lead sponsor of 155 studies on the registry; 90 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.
Drug: Apatinib · Drug: POF
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.
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Fujian Cancer Hospital