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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 TypeStomach & Oesophageal
Trial TypeTreatment
PhasePhase III
Age Range18 years to 75 years
SexBoth
Tumour Stream Esophageal squamous cell carcinoma
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2018-12-13
Anticipated End Date2022-07-30

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6140
Principal InvestigatorProfessor Tim Price
Recruitment StatusNot Yet Recruiting