Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Paclitaxel

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.