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Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma

Trial Status: Active

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.

Inclusion Criteria

  • Key Inclusion Criteria: - 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 Key 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 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.

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Innovent Biologics (Suzhou) Co. Ltd.

  • Primary ID CIBI308A301
  • Secondary IDs NCI-2020-03808
  • Clinicaltrials.gov ID NCT03748134