drugset / Trial / NCT04926545
XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study)
Completed
24 enrolled
Guangzhou University of Traditional Chinese Medicine
University of Houston · collab
Non-randomizedSingle-groupOpen-labelBasic science
Summary
Run-in safety study, to determine the safety of co-administration of irinotecan, raloxifene, and Xiao Chai Hu Tang (XCHT), and to optimize the blood collection time points for pharmacokinetic (PK) study for another randomized control trial.
Timeline
- Start
- 2021-07-16
- Primary completion
- 2024-07-20
- Completion
- 2024-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xiao Chai Hu Tang | Traditional medicine (herbal / TCM) | 9 g | Oral |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |