NCT04121039

Study of the Apatinib Combine With POF Versus POF in Gastric Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Adenocarcinoma
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
DRUG	POF	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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-12-01
• Completion: 2023-12-01
• First posted: 2019-10-09
• Last updated: 2019-10-09

Locations

1 site across 1 country: China