NCT03748134

Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Sintilimab	For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
DRUG	Cisplatin	75mg/m\^2 IV Q3W day 1
DRUG	Paclitaxel	87.5 mg/m\^2 IV Q3W day 1, day 8 for first cycle and 175mg/m\^2 IV Q3W day 1 after first cycle
DRUG	Fluorouracil	800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
DRUG	Placebo	For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1

Timeline

• Start date: 2018-12-24
• Primary completion: 2021-09-09
• Completion: 2023-07-29
• First posted: 2018-11-20
• Last updated: 2023-10-24

Locations

48 sites across 7 countries: United States, Australia, Belgium, China, France, Hungary, Spain

Regulatory

• FDA-regulated drug study