Summary
This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.
After the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma
Official Title
A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)
Keywords
Esophageal Squamous Cell Carcinoma, ESCC, Esophageal Cancer, Esophageal Neoplasms, Esophageal Neoplasms Malignant, Neoplasms, Squamous Cell, Esophageal Diseases, Carcinoma, Squamous Cell, Gastrointestinal Diseases, Paclitaxel, Cisplatin, Fluorouracil, Antineoplastic Agents, Anti-PD-1, Sintilimab, Carcinoma, Squamous Cell Carcinoma, Sintilimab + chemotherapy