Locally advanced esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Sintilimab + chemotherapy + radiotherapy (simultaneous)
Control group:Placebo + chemotherapy + radiotherapy (concurrent)
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient or the patient's legal representative can sign a written informed consent form, and can understand and agree to follow the research requirements; 2. Aged between 18 and 75 years when signing the informed consent; 3. Histologically confirmed locally advanced ESCC and suitable for CCRT, including: Stage II-IVa (AJCC 8th edition [Rice et al, 2017]) inoperable ESCC patients (medically ineligible for surgery or refusing surgery) and ESCC stage M1 patients with only supraclavicular lymph node metastases; 4. There are measurable and/or unmeasurable lesions that meet the definition of RECISTv1.1; 5. ECOG fitness status=1.5x10^9/L, platelets>=100x10^9/L, hemoglobin>=90g/L; (2) Serum creatinine =60mL/min/1.73m^2; (4) Serum total bilirubin 2 weeks of treatment prior to enrollment. 8. Females of childbearing potential must voluntarily take high-efficiency contraceptive measures during the study period and within >= 120 days after the last dose of sintilimab, and the urine or serum pregnancy test results are negative within = 120 days after the last sintilimab administration.
Exclusion criteria
Exclusion criteria: 1. A history of fistula caused by primary tumor infiltration; 2. Patients with high risk of esophageal fistula or signs of esophageal perforation; 3. Evidence of distant metastasis (M1 disease AJCC 8th edition; 4. History of esophageal cancer surgery; 5. There are indications of severe malnutrition; 6. There is clinically uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage or medical intervention (within 2 weeks before randomization); 7. Known intolerance or resistance to chemotherapy specified in the trial protocol; 8. Received radiotherapy, chemotherapy, targeted therapy, esophageal surgery or anti-PD-1, PD-L1, PD-L2 therapy or other tumor immunotherapy; 9. Patients with active autoimmune disease or a history of autoimmune disease but may relapse Note: Patients with the following diseases are not excluded and can enter further screening: (1) Controllable type I diabetes; (2) Hypothyroidism (which can be controlled only with hormone replacement therapy); (3) Controllable celiac disease; (4) Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia); (5) Any other disease that is not expected to recur if there is no external inducement; 10. Except for the specific cancers being studied in this study and locally recurrent cancers that have been cured (eg, resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast), other active malignancies 10 mg/day prednisone or equivalent doses of similar drugs) or other immunosuppressive agents within 1 abnormal or >= 3 hypoalbuminemia; 13. History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic disease, including pulmonary fibrosis, acute lung disease, etc.; 14. Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral treatment within 14 days before enrollment; 15. Known history of HIV infection; 16. Major surgery <= 28 days before enrollment; Note: Minimally invasive procedures (eg, Peripheral Puncture Central Catheter [PICC]) are not considered major surgery. 17. Received allogeneic stem cell transplantation or organ transplantation; 18. Presence of any of the following cardiovascular risk factors: (1) Cardiogenic chest pain within <= 28 days prior to enrollment, defined as moderate pain that restricts instrumental activities of daily living; (2) Symptomatic pulmonary embolism occurred within <=28 days before enrollment; (3) Acute myocardial infarction occurred within <=6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Health-related quality of life; | — |
Countries
China
Contacts
Public ContactLi Tao
Outcome results
None listed