ORIENT-15
01 Dec 2020
Trial 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.
Acronym:
ORIENT-15
ACTRN/NCT /ethics:
NCT03748134
Scientific 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)
Sponsor / Cooperative group:
Innovent Biologics (Suzhou) Co. Ltd.
Trial & Patient Characteristics
| Cancer Type | Stomach & Oesophageal |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years to 75 years |
| Sex | All |
| Tumour Stream | Esophageal squamous cell carcinoma |
| Cancer Stage | Locally Recurrent or Locally Advanced; Metastatic or Widespread |
| Anticipated Start Date | 2018-12-13 |
| Anticipated End Date | 2022-07-30 |
Participating Hospitals
| Hospital | The Queen Elizabeth Hospital |
|---|---|
| Clinical Trial Coordinator | Pamela Cooper |
| pamela.cooper@sa.gov.au | |
| Phone | 08 8222 6140 |
| Principal Investigator | Professor Tim Price |
| Recruitment Status | Recruiting |