Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer
Condition: Esophageal Carcinoma
MeSH terms: Esophageal Neoplasms
Intervention: camrelizumab; Docetaxel; Irinotecan
Intervention description: Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks; Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks; Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks
Intervention MeSH terms: Docetaxel; Irinotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 457.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      In this study, participants with advanced or metastatic squamous cell carcinoma of the
      esophagus that has progressed after first-line standard therapy will be randomized to receive
      either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel
      or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong
      overall survival (OS) as compared to treatment with standard therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age: 18-75 years, male or female.

          2. Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus,
             locally advanced, unresectable disease, recurrent or Metastatic disease.

          3. Fail to the first-line standard therapy.

          4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

          5. Can provide either a newly obtained or archival tumor tissue sample.

          6. ECOG 0-1.

          7. Life expectancy of greater than 12 weeks.

          8. Adequate organ function.

          9. 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.

         10. Patient has given written informed consent.

        Exclusion Criteria:

          1. 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.

          2. Known central nervous system (CNS) metastases.

          3. Subjects with any active autoimmune disease or history of autoimmune disease.

          4. 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;

          5. 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);

          6. History of Interstitial Pneumonia or received Corticosteroids for non-infectious
             pneumonitis.

          7. Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C.

          8. BMI, <18.5mg/m2 or ≥10% weight lost before screening.

          9. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.

         10. Known history of hypersensitivity to macromolecular protein preparation or any
             components of the SHR-1210 formulation, allergy, hypersensitivity, or contraindication
             to docetaxel, or irinotecan.

         11. 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.

         12. 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.

         13. Currently participating or has participated in a study within 4 weeks of the first
             dose of study medication.

         14. Received a live vaccine within 4 weeks of the first dose of study medication.

         15. Pregnancy or breast feeding.

         16. According to the investigator, other conditions that may lead to stop the research.