JS001 Combined With TP as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma

Exclusion Criteria

• •1. Known allergy to study drug or excipients, or allergy to similar drugs;
• •2. Received anti-tumor cytotoxic drug therapy, biological drug therapy (such as monoclonal antibody), immunotherapy (such as interleukin-2 or interferon) or other research drug therapy within 4 weeks before enrollment.
• •3. Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment.
• •4. Patients received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases.
• •5. Major surgery was performed or not completely recovered from the previous surgery within 4 weeks before enrollment (the definition of major surgery refers to the level 3 and level 4 surgery specified in the administrative measures for clinical application of medical technology implemented on May 1, 2009).
• •6. The toxicity of previous anti-tumor therapy has not recovered to CTCAE \[version 4.03\] 0-1, except for the following cases: a) lipsotrichia；b) Pigmentation;c) Peripheral neurotoxicity has recovered to \< CTCAE 2;d) The long-term toxicity caused by radiotherapy could not be recovered according to the judgment of the researchers;
• •7. Subjects with clinically symptomatic CNS metastases and/or cancerous meningitis. The subjects who have received brain or meningeal metastasis treatment in the past, if the clinical stability has been maintained for at least 2 months, and the systemic hormone treatment has been stopped for more than 4 weeks can be included.
• •8. Have or are currently suffering from other malignancies (except for non melanoma basal cell carcinoma of the skin, breast / cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment in the past five years).
• •9. Subjects have any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood who have completely remission and do not need any intervention in adulthood can be included; subjects with asthma requiring bronchodilator for medical intervention can not be included).
• •10. Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell costimulation or checkpoint pathway).
• •11. Subjects with active pulmonary tuberculosis (TB) are receiving antituberculosis treatment or received antituberculosis treatment within one year before screening.
• •12. Patients with complications requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effect (dose \> 10mg / day of prednisone or other therapeutic hormones).
• •13. Received any anti infection vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment.
• •14. Pregnant or lactating women.
• •15. HIV positive.
• •16. HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 CPS / ml).
• •17. HCV antibody positive.
• •18. Researchers believe that it can affect the compliance of the protocol, or affect the subject to sign the informed consent(ICF), or any other disease or condition of clinical significance that is not suitable to participate in this clinical trial.
• •19. There are clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.