Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer

Inclusion criteria

• age: 18-75 years, male or female.
• Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease, recurrent or Metastatic disease.
• Fail to the first-line standard therapy.
• Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
• Can provide either a newly obtained or archival tumor tissue sample.
• ECOG 0-1.
• Life expectancy of greater than 12 weeks.
• Adequate organ function.
• Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-1210 or through 180 days after the last dose of docetaxel or irinotecan.
• Patient has given written informed consent.

Exclusion criteria

• Has a known additional malignancy within the last 5 years before study treatment with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
• Known central nervous system (CNS) metastases.
• Subjects with any active autoimmune disease or history of autoimmune disease.
• Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
• Active infection or an unexplained fever > 38.5°C before two weeks of randomization (subjects with tumor fever may be enrolled at the discretion of the investigator);
• History of Interstitial Pneumonia or received Corticosteroids for non-infectious pneumonitis.
• Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C.
• BMI, <18.5mg/m2 or ≥10% weight lost before screening.
• Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
• Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation, allergy, hypersensitivity, or contraindication to docetaxel, or irinotecan.
• Concurrent medical condition requiring the use of cortisol ( >10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent for replacement therapy.
• Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
• Currently participating or has participated in a study within 4 weeks of the first dose of study medication.
• Received a live vaccine within 4 weeks of the first dose of study medication.
• Pregnancy or breast feeding.
• According to the investigator, other conditions that may lead to stop the research.