Neuroendocrine Carcinoma of the Bladder Clinical Trial
Official title:
Phase II/III Trial of Simmtecan and 5-FU/LV Regimen (FOLFSIM) Plus Teripalimab Versus EP/EC in Advanced or Metastatic Neuroendocrine Carcinoma
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.
This is a Phase II/III, randomized, two-part, multi-center study, in which subjects with
advanced or metastatic neuroendocrine carcinoma will be enrolled.
This study will be conducted in two parts:
Part 1, the Phase II study was to: (i) evaluate the safety and tolerability of the FOLFSIM
regimen plus Toripalimab; and (ii) identify the recommended dose; (iii) assess the antitumor
activity; (iv) the pharmacokinetic (PK) parameters of the drugs in the regimen.
Part 2, the Phase III study was to verify inferiority of FOLFSIM regimen plus Toripalimab
compared with the current standard chemotherapy (EP/EC regimen) in the first-line treatment
of advanced or metastatic neuroendocrine carcinoma.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06091124 -
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Neuroendocrine Bladder Carcinoma
|
Phase 2 |