Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )
Completed · Phase 3 · Has a placebo group
Conditions studied: Esophageal Squamous Cell Carcinoma
In brief
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
Key facts
- Study ID
- NCT03748134
- Run by
- Innovent Biologics (Suzhou) Co. Ltd.
- People needed
- 746
- Starts
- 2018-12-24
- Expected to finish
- 2023-07-29
- Last updated by the study team
- 2023-10-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center — Anaheim, California, United States
- UC Irvine — Orange, California, United States
- Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
- IACT Health - John B. Amos Cancer center — Columbus, Georgia, United States
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- Texas Oncology, P.A. — Austin, Texas, United States
- Northwest Cancer Specialists, P.C. — Vancouver, Washington, United States
- Border Medical Oncology — East Albury, New South Wales, Australia
- The Queen Elizabeth Hospital — Woodville South, South Australia, Australia
- Austin Hospital — Heidelberg, Victoria, Australia
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
- St John of God Subiaco Hospital — Subiaco, Western Australia, Australia
- University Hospital Gent — Ghent, Corneel Heymanslaan 10, Belgium
- Universitair Ziekenhuis Leuven — Leuven, Herestraat 49, Belgium
- Cliniques Universitaires Saint-Luc Av. — Brussels, Hippocrate 10, Belgium
- Institut Jules Bordet — Brussels, Belgium
- Centre Hospitalier Regional de Verviers — Verviers, Belgium
- Beijing Cancer Hospital — Beijing, China
- Hôpital Jean Minjoz — Bettancourt-la-Ferrée, France
- Institut Bergonié — Bordeaux, France
- Centre François Baclesse — Caen, France
- CHU Estaing — Clermont-Ferrand, France
- CHU Estaing — Clermont-Ferrand, France
- Faculte de Medecine — Dijon, France
- Universite de Bourgogne - Faculte de Medecine - INSERM U866 — Dijon, France
Full record on ClinicalTrials.gov
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