for people ages 18-75 (full criteria)
at Orange, California and other locations
study started
estimated completion



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.

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)


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 Sintilimab + chemotherapy


You can join if…

Open to people ages 18-75

  • Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic ESCC (excluding mixed adenosquamous carcinoma and other histological subtypes)
  • ECOG PS of 0 or 1
  • Subject must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery. For subjects who have received (neo)adjuvant or definitive chemotherapy/radiochemotherapy, time from the completion of last treatment to disease recurrence must be > 6 months Could provide archival or fresh tissues for PD-L1 expression analysis with obtainable results#
  • Have at least one measurable lesion as per RECIST v1.1

You CAN'T join if...

  • ESCC with endoscopy-confirmed near-complete obstruction requiring interventional therapy
  • Post stent implantation in the esophagus or trachea with risk of perforation
  • Received systemic treatment for advanced or metastatic ESCC.
  • Received a Cumulative dose of cisplatin > 300 mg/m2 within 12 months to randomization.
  • High risk of hemorrhage or perforations due to tumor invasion in adjacent organs (aorta or trachea), or have fistula formation.
  • Hepatic metastasis > 50% of the total liver volume.
  • Received palliative therapy for a local lesion within 2 weeks prior to the first dose.
  • Received systemic treatment with Chinese traditional medicines with anti-cancer indications or immunomodulators (including thymosins, interferons, and interleukins) within 2 weeks prior to the first dose of study treatment.
  • Received systemic immunosuppressants within 2 weeks prior to randomization, excluding local use of glucocorticoids administered by nasal, inhaled, or other routes, and systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone or equivalents), or glucocorticoids to prevent allergies to contrast media.


  • UC Irvine accepting new patients
    Orange California 92868 United States
  • St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center accepting new patients
    Anaheim California 92835 United States


accepting new patients
Start Date
Completion Date
Innovent Biologics (Suzhou) Co. Ltd.
Phase 3
Study Type
Last Updated