Phase 3Completed
A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma
A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1001 in Combination With Fluorouracil and Cisplatin (FP) Compared to Placebo in Combination With FP as First-Line Therapy in Subjects With Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
- Sponsor
- CStone Pharmaceuticals (Industry)
- Enrolment
- 540 enrolled
- Conditions
- Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
- Interventions
- CS1001+ Fluorouracil+Cisplatin; Placebo+ Fluorouracil+Cisplatin
- Ages
- adults, older adults
- Registry
- NCT04187352
Full record on ClinicalTrials.gov
From the registry
Phase III Study to Investigate the Efficacy and Safety of CS1001 or Placebo in Combination with FP as First-Line Therapy in Subjects with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Primary outcomes
- Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Overall survival (OS)
History
Last registry update
Primary completion
Started
Registered