an unresectable locally advanced esophageal squamous cell carcinoma
Conditions
Interventions
Sponsors
Second People's Hospital of Changzhou City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in the study, signed the informed consent, showed good compliance and cooperated with follow-up; 2. Male or female aged 18 to 75 years old; 3. Patients with histologically confirmed locally advanced esophageal squamous cell carcinoma with stage II-IIA unresectable clinical staging (including unresectable, contraindications to surgery, or refusal to undergo surgery) (according to AJCC staging 8, pre-treatment clinical staging: CT1N2-3M0, CT2-4BN0-3M0); 4. Physical condition score ECOG0-1;5. Expected survival >=3 months; 6. No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency; 7. Neutrophils >=1.5x10^9/L; Hemoglobin >=9g/dL; Platelet >=75x10^9/L; Total bilirubin <=1.5 ULN; AST(SGOT) and ALT(SGPT)<=2.5 ULN; Creatinine <=1.5 ULN.
Exclusion criteria
Exclusion criteria: 1. Esophageal perforation or hematemesis; 2. With any active autoimmune disease or a history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, myocarditis, nephritis, thyroid function, thyroid function reduce (hormone replacement therapy after effective can be incorporated into), etc.), and use of immunosuppressant within 28 days;Medical history, except for the use of toxic hormones for treatment of chemoradiotherapy; 3. Adverse events (such as neurotoxicity) that are difficult to recover quickly due to treatment before the first use of the study drug but have not recovered (i.e., level 1 or reach baseline level) can be included in the study as determined by the investigator; 4. According to the researchers' judgment, there was still non-infectious pneumonia caused by previous radiotherapy and chemotherapy; 5. Have received or are receiving other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L1; 6. Is known to be allergic to macromolecular protein preparations or to any carrizumab (SHR-1210) or its components in the preparations; 7. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHAII heart failure or above; (2) unstable angina; (3) Had myocardial infarction within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 8. Patients with congenital or acquired immunodeficiency (such as HIV-infected persons), active hepatitis B (HBV-DNA>=104 copies/ml) or hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the assay method) or active tuberculosis; 9. Active infection or unexplained fever of > 38.5 degree C occurred within 2 weeks prior to randomization (subject fever due to tumor can be included as judged by the investigator); 10. Fertile men or women are unwilling to take contraceptive measures in the trial, and female patients are pregnant or lactating; 11. As judged by the Investigator, subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental illness) requiring combined treatment, family or social factors that may affect the safety of subjects or the data collection of the study; 12. A history of interstitial lung disease, a history of non-infectious pneumonia, and grade >=3 pulmonary insufficiency confirmed by pulmonary function examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DOR; | — |
Countries
China
Contacts
Public ContactJingping Yu
Second People's Hospital of Changzhou City
Outcome results
None listed