drugset / Trial / NCT03992911
Safety and Efficacy of FOLFSIM Plus Toripalimab in the Treatment of Advanced or Metastatic Neuroendocrine Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of Simmtecan and the 5-FU/LV regimen (FOLFSIM regimen) plus Toripalimab. Phase III is aimed to verify inferiority of the overall survival of FOLFSIM regimen plus Toripalimab in comparison with EP/EC in advanced or metastatic neuroendocrine cancer.
Timeline
- Start
- 2019-06-19
- Primary completion
- 2022-06-20
- Completion
- 2023-06-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Simmtecan | Unknown | 80 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Subject | l-LV | Unknown | 400 mg/m2 | Intravenous |