NCT03707639

Study of the Combination of Apatinib and POF

Phase II Study of the Combination of Apatinib and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Adenocarcinoma

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: 2018-11-01
• Primary completion: 2019-10-01
• Completion: 2020-11-01
• First posted: 2018-10-16
• Last updated: 2018-10-16

Locations

1 site across 1 country: China