Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Sindilizumab combined with chemotherapy induction therapy followed by concurrent chemoradiotherapy
Control group:Radical concurrent chemoradiotherapy
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent in person; 2. Age 18-75, regardless of gender; 3. Esophageal squamous cell carcinoma was confirmed histologically or cytologically; 4. Staging reference UICC 8th; 5. Physical condition score ECOG 0-1 (see Annex 2 for ECOG scoring criteria); 6. Expected survival >=3 months; 7. No serious hematopoietic function, abnormal heart, lung, liver or kidney function and immune deficiency; 8. Neutrophils >=1.5*10^9/L; Hemoglobin >=9g/dL; Platelet >=100×10^9/L; Total bilirubin <=1.5 times the upper limit of normal value; AST(SGOT) and ALT(SGPT)<=2.5 times the upper limit of normal value; Creatinine <=1.5 times the upper limit of normal value.
Exclusion criteria
Exclusion criteria: 1. Esophageal perforation or hematemesis; 2. With any active autoimmune disease or a history of autoimmune diseases, 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 in the use of immunosuppressants within 28 days, Except for the use of hormones to deal with toxicity caused by radiation and chemotherapy; 3. Have received or are currently receiving other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1; 4. Known to be allergic to large protein preparations, or to Sindilizumab and the ingredients in the preparations; 5. Have uncontrolled cardiac clinical symptoms or disease, such as: (1) NYHA class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular arrhythmias or ventricular arrhythmias requiring clinical intervention; 6. Patients with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA>=10^4 copy number/ml) or hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection method) or active tuberculosis; 7. Active infection or unexplained fever > 38.5? within 2 weeks prior to screening (according to the judgment of the investigator, subjects with fever due to tumor can be included in the study); 8. Fertile men or women were unwilling to use contraception during the trial, and women were pregnant or breastfeeding; 9. In the investigator's judgment, the subjects had other factors that might cause them to be forced to terminate the study. For example, they have other serious medical conditions (including mental illness) requiring concomitant treatment, family or social factors that may affect the safety of the subjects, or the collection of test data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective remission rate;Safety; | — |
Countries
China
Contacts
Public ContactJinjun Ye
Jiangsu Cancer Hospital
Outcome results
None listed