drugset / Trial / NCT03606928
mFLOT Chemotherapy as First-line Treatment in GC
NaSingle-groupOpen-labelTreatment
Summary
A single center phase 1b/2 trail to identified suitable dosage and its efficacy of modified FLOT regime in Chinese gastric cancer patients. This trial is designed to identified recommended phase II dose (RP2D) of modified FLOT in Chinese patients, and to evaluate the efficacy of modified FLOT regime as first-line for advanced or metastatic gastric cancer. This trial is in 2 stages: the first stage will establish the maximum tolerated dose (MTD) and RP2D of docetaxel and oxaliplatin in FLOT regime. In the second stage, the efficacy of modified FLOT will be assessed by response rate.
Timeline
- Start
- 2018-07-01
- Primary completion
- 2019-11-09
- Completion
- 2020-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 65 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2200 mg/m2 | Intravenous |