Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.

Inclusion criteria

• Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
• No previous systemic anti-tumor treatment;
• Subjects must have at least one measurable tumor lesion per RECIST 1.1;
• Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
• ECOG: 0-1;
• Adequate organ and bone marrow function;

Exclusion criteria

• Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
• Prior therapy as follow:

• Anti-PD-1 or anti-PD-L1;
• Any experimental drugs within 4 weeks of the first dose of study medication;
• Received major operations or serious injuries within 4 weeks of the first dose of study medication;
• Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
• Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
• Subjects with any active autoimmune disease or history of autoimmune disease;
• Pregnancy or breast feeding;