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

Exclusion Criteria

• •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 and the last cisplatin dose was within 12 months of randomization or the first dose of study treatment in the open-label phase.
• •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.