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

  • End date
    Jun 30, 2025
  • participants needed
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 7 October 2022
measurable disease
squamous cell carcinoma
chemotherapy regimen
metastatic esophageal squamous cell carcinoma


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.

After the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma

Condition Esophageal Squamous Cell Carcinoma
Treatment fluorouracil, cisplatin, Placebo, Paclitaxel, Sintilimab
Clinical Study IdentifierNCT03748134
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on7 October 2022


Yes No Not Sure

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

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
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