esophageal squamous cell carcinoma
Conditions
Interventions
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria of esophageal cancer: 1) Histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma of the esophagus. Clinical staging T3-4N0M0, T1-4N+M0,?-?a (AJCC 8th); 2) Intolerant or refractory to surgery or unresectable disease or cervical esophageal cancer; 3) No prior radiation therapy for esophageal cancer; 4) No risk of major hemorrhage or esophageal fistula, for example, large ulcer at the lesion is considered as the risk for major hemorrhage and esophageal fistula, the patient is not suitable to be enrolled. The risk of hemorrhage should be closely evaluated for the subjects with direct invasion to adjacent organs, for example, aorta or trachea (T4b disease) prior to enrollment, and the sponsor needs to be consulted prior to enrollment; 2. General inclusion criteria: 1) Signed informed consent; 2) Male or female aged 18 to 75 years; 3) ECOG score 0 or 1; 4) Body weight more than 35kg; 5) No more than 10% weight loss in 3 months; 6) Expected survival longer than 3 months; 7) Agreement upon providing previously reserved tumor tissue specimen or biopsied tumor lesion tissue for biomarker analysis; 8) At least one measurable lesion in accordance with RECIST 1.1 (only when clear progression of disease occurs after radiotherapy for the previously irradiated lesion, the lesion can be used as measurable lesion); 9) Good organ function level: Hematology: white blood cell >=4x10^9/L, neutrophil >=2x10^9/L, hemoglobin >=9 g/dL and platelet =3g/dL; International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) -1 year). Having childbearing potential, serum pregnancy test negative at screening (within 7 days prior to the first dose of study drug), and no adequate contraceptive measures taken prior to entry in the study and throughout the study, until 60 days after the last dose of the study drug. The adequate contraceptive measure taken continuously in accordance with the instruction on the contraceptive product and physician's guidance is defined as below: Any intrauterine device confirmed to have a failure rate for contraception less than 1% per year Dual barrier contraception is defined as the condom with spermicidal gel, foam, suppository or film; or diaphragma with spermicide; or male condom and diaphragma.
Exclusion criteria
Exclusion criteria: 1. Cancer-specific exclusion criteria: 1) Evidence of distant metastasis 2) GEJ or cardia involved; 3) History of malignant tumors except esophageal cancer within 5 years prior to randomization, however, the risk of metastasis or death can be neglected [e.g., expected 5-year survival rate> 90%], and except the malignant tumors that 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; 4) Chemotherapy within 4 weeks prior to enrollment, or radiopharmaceutical therapy within 8 weeks 2. General medical exclusion criteria: 1) Women who are pregnant or lactating, or plan to be pregnant during the study; 2) History of serious allergic reaction, anaphylactoid or other hypersensitive reactions to chimeric or humanized antibody or fusion protein; 3) Known allergy or hypersensitivity to the biological products manufactured from Chinese hamster ovary cells or any component of JS001 preparation; 4) 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: The coverage area of rashes must be lower than 10% of body surface area (BSA); The disease has been sufficiently controlled at baseline and only low-potency topical steroid therapy is needed; No acute exacerbation of underlying diseases in the past 12 months [no need of PUVA (Psoralen plus ultraviolet A radiation), methotrexate, retinol, biological preparation, oral calcineurin inhibitor, high-potency or oral steroid therapy]. 5) History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterative bronchiolitis), drug induced pneumonia, idiopathic pneumonia interstitial pneumonia or evidence of active pneumonia found during chest CT scanning for screening; 6) Patients with positive result of human immunodeficiency virus (HIV) test; 7) Patients with hepatitis B (known positive HBV surface antigen HBsAg and HBV DNA >=1000 cps/ml or 200 IU/ml or higher than upper limit of normal at each study site) or hepatitis C: Patients with previous hepatitis B virus (HBV) infection or recovery of HBV infection (defined as positive hepatitis B core antibody [HBcAb] and negative HBsAg) can be included in this study. Such patients must undergo HBV deoxyribonucleic acid (DNA) testing prior to randomization, and can participate in this study only when HBV DNA is negative (HBV DNA ?1000cps/ml or 200IU/ml or Below the upper limit of its normal value); In patients with positive hepatitis C virus (HCV) antibody, only
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Overall response rate;Disease control rate;Duration of response;Time to response;One year progression free survival rate;One year overall survival rate;Two year progression free survival rate;Two year overall survival rate;Quality of life; | — |
Countries
China
Contacts
Public ContactLvhua Wang
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed