Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:PD-1 antibody combined with platinum-containing chemotherapy
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent prior to implementing any trial-related procedures; 2. No gender limit, aged 18-80 years; 3. Patients diagnosed as esophageal squamous cell carcinoma by histopathological examination of primary biopsy; 4. Patients (CT2-4N1-3M0)II-IVA who were deemed operable and required neoadjuvant therapy by imaging and esophagoscopy; 5. According to imaging and esophagoscopy, the main body of the tumor was located in the thoracic part of the esophagus; 6. According to the response evaluation criteria for solid tumors (RECIST, version 1.1), at least one lesion can be measured by imaging; 7. The patient had not received any previous antitumor therapy, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 8. ECOG score 0-1; 9. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other malignant tumors that have not been cured within 5 years before the first dose; 2. Patients with possible tracheoesophageal fistula or aortoesophageal fistula; 3. Currently participating in interventional clinical research and treatment; 4. Received systemic systemic therapy with proprietary Chinese medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before the first dose; 5. Active autoimmune disease requiring systemic therapy occurred within 2 years before the first dose; 6. Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study; 7. Known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Known allergy to the active ingredient or excipient of sindilizumab; 9. Not sufficiently recovered from toxicity and/or complications caused by any intervention before starting treatment; 10. Known infectious diseases, family history; 11. Pregnant or lactating patients; 12. The presence of any serious or uncontrolled systemic disease; 13. Abnormal medical history or evidence of disease, treatment or laboratory test values that may interfere with the results of the trial or prevent the participant from participating in the study, or other conditions that the investigator considers to be inappropriate for enrollment, and the investigator considers that there are other potential risks that are inappropriate for the participant to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Pathological complete response rate;Major pathological response rate; | — |
Countries
China
Contacts
Public ContactLi Bin
Lanzhou University Second Hospital
Outcome results
None listed