drugset / Trial / NCT03707639
Study of the Combination of Apatinib and POF
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-11
- Primary completion
- 2019-10
- Completion
- 2020-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |