esophageal squamous carcinoma
Conditions
Interventions
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study and signed informed consent; 2. Aged >= 18 years, no gender limit; 3. Esophageal squamous cell carcinoma confirmed by cytology or histology; 4. Patients with locally advanced cervical lymph node metastasis; 5. No previous treatment for esophageal primary tumors (such as chemotherapy and radiotherapy, immunotherapy or biotherapy, etc.); 6. The primary tumor was evaluable, with at least 1 measurable lesion present according to RECIST1.1; 7. No distant viscera metastasis; 8. The physical status score of the Eastern Oncology Consortium (ECOG) was =3 months; 10. The following criteria are met if the major organs are functioning properly: (1) Blood routine examination: 1) HBG>=90g/L; 2) ANC>=1.5x10^9/L; 3) PLT >=80x10^9/L; (2) Biochemical examination: 1) ALB>=30g/L; 2) ALT and AST=60ml/min; 11. Lung function: FEV1/FVC?70%, FEV1?50% normal value, the percentage of DLCO (lung dispersion function) measured value and estimated value >80%; 12. Women of childbearing age must undergo a pregnancy test that is negative within 7 days before starting treatment; 13. All enrolled patients should take adequate contraceptive measures throughout the treatment period and for 6 months after completion; 14. No serious hematopoietic function, cardiac function abnormality or immune deficiency; 15. There was no esophageal perforation or active esophageal bleeding, and no intrusion of trachea or thoracic great vessels.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or has autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood who can be included in adulthood without any intervention; Patients with asthma requiring medical intervention with bronchodilators are not included); 2. Patients who were taking immunosuppressant or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continued to use within 2 weeks prior to enrollment; 3. Previously received other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1; 4. Patients with any severe and/or uncontrolled disease; 5. Active or uncontrolled severe infection; 6. Liver diseases such as decompensated liver disease, active hepatitis B or C; 7. Patients whose imaging shows that the tumor has invaded important blood vessels or whose tumor is determined by the investigator to be highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 8. Pregnant or lactating patients; 9. Patients who have had other malignancies within 5 years (except basal cell carcinoma of the skin and carcinoma in situ of the cervix, which have been cured); 10. Patients with a history of psychotropic substance abuse and unable to abstain or patients with mental disorders; 11. Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study; 12. Those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Pathological complete response rate;RFS, relapse free survival;ORR, objective response rate;1Y-OSR, one year overall survival rate;Safety evaluation; | — |
Countries
China
Contacts
Public ContactMei Xinyu
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed