drugset / Trial / NCT03618758
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Phase 1/2
Completed
35 enrolled
Seoul National University Bundang Hospital
B. Braun Korea Co., Ltd. · collabBoryung Pharmaceutical Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results. This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.
Timeline
- Start
- 2018-12-24
- Primary completion
- 2023-08-31
- Completion
- 2023-12-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 40 mg/m2 | Other |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | Other |
| Background | Leucovorin | Small molecule | 100 mg/m2 | Other |
| Background | Oxaliplatin | Small molecule | 100 mg/m2 | Other |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Other |