drugset / Trial / NCT03788174

Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma

NCT03788174

Phase 2 Unknown 26 enrolled Fujian Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2019-02-01
Primary completion
2019-12
Completion
2020-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Levoleucovorin Unknown 200 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Paclitaxel Small molecule 135 mg/m2 Intravenous
Subject Rivoceranib Small molecule 500 mg Oral
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous