Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma

Key inclusion criteria (0 listed)

Key exclusion criteria (16 listed)

• Active or untreated CNS metastasis determined through CT or magnetic resonance imaging (MRI) evaluation in screening period and previous radiological evaluation (e.g., brain or leptomeningeal metastasis). Patients who have received previous treatment of brain or meningeal metastases, who have been stabilized for at least 2 months and discontinued systemic hormone therapy (> 10 mg/d of prednisone or equivalent) for > 4 weeks prior to randomization; Uncontrolled tumor related pain; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once per month or more frequent); indewlling catheter (e.g. PleurX®) is allowed; Uncontrollable or symptomatic hypercalcemia (ionized calcium>1.5 mmol/L or calcium >12 mg/dL or corrected serum calcium >ULN); History of malignant tumors except esophageal cancer within 5 years prior to randomization, but except the malignant tumors that risk of metastasis or death can be neglected [e.g., expected 5-year survival rate> 90%], and are expected to be cured after treatment, for example, appropriately treated carcinoma in situ of cervix, basal or squamous cell skin cancer, local prostate cancer treated with radical operation, and ductal carcinoma in situ treated with radical operation; Palliative Radiotherapy within 4 weeks prior to enrollment, or radiopharmaceutical therapy within 8 weeks, however, except locally palliative radiotherapy for bone metastatic lesions; in case of symptomatic lesion suitable for palliative chemotherapy, the therapy should be given prior to enrollment. The effect of previous radiotherapy has been recovered. The shortest recovery period is not required; Subjects with bone metastases of multiple vertebra are prone to fractures and may cause risk of paraplegia, except for Subjects who are assessed as stable and do not need to be treated for the time being evaluated by a specialist.
• Subjects with advanced tumors spreading to vital organs and being in risk of developing life-threatening complications in the short term ( eg. metastatic disease burden of liver ≥ 50% of total liver volume).
• Subjects with known complete obstruction under endoscopy requiring interventions or surgery to remove obstruction and who have undergone tracheal or esophageal stenting; Subjects whose BMI are less than 17.5, or body weight decrease >10% within 2 months prior to first dose of study treatment (considering changes of massive pleural effusion and ascites) or with severe malnutrition as indicated by other indicators.
• Women who are pregnant or lactating, or plan to be pregnant during the study; History of serious allergic reaction, anaphylactoid or other hypersensitive reactions to chimeric or humanized antibody or fusion protein; Known allergy or hypersensitivity to the biological products manufactured from Chinese hamster ovary cells or any component of JS001 preparation; History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, glomerulonephritis; Patients with hypothyroidism who receive stable-dose thyroid hormone replacement therapy can be enrolled in this study (the replacement therapy for hypothyroidism is seen in Appendix 6); Patients with type I diabetes whose blood glucose can be controlled through stable-dose insulin can be enrolled in this study;
• Patients with eczema, psoriasis, chronic lichen simplex or only the dermatological manifestations of vitiligo (e.g., patients with psoriatic arthritis will be excluded from the study) are allowed to be enrolled in this study if they meet the following conditions: