esophageal carcinoma
Conditions
Interventions
treatment group:Serplulimab
Sponsors
Beijing Cancer Hospital (Peking University Cancer Hospital and Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 75 years old, regardless of gender; 2) Pathological diagnosis of locally advanced resectable thoracic esophageal squamous cell carcinoma, with imaging (enhanced CT/MRI) staging of cT1N1N2 or cT2-3N0-2; 3) Immunohistochemical detection of PD-L1 CPS >= 10 in tumor tissue specimens before treatment; 4) Has not received any previous treatment for locally advanced esophageal squamous cell carcinoma (including chemotherapy, radiotherapy, or immunotherapy); 5) According to the activity status rating scale developed by the Eastern Cooperative Oncology Group (ECOG) in the United States, patients with ECOG scores of 0-1 were included in the evaluation; 6) Adequate organ function: a) Blood routine (no blood transfusion within 14 days before treatment, no use of granulocyte colony-stimulating factor, no use of other medications for correction) i. Neutrophil count (NE)>1.5 * 10^9/L; ii. Hemoglobin count (HGB)>90 g/L; iii. Platelet count (PLT)>100 * 10^9/L; b) Coagulation function (no blood product transfusion within 14 days before treatment) i. International normalized ratio (INR) or prothrombin time (PT) = 50mL/min; ii. Total bilirubin (TBIL) 2.7 g/dL 7) During urine test strips or routine urine tests, the patient's urine protein is <= 1+; 8) Can provide written informed consent (ICF) and understand and agree to comply with research requirements and evaluation schedules; 9) Female patients must undergo surgical sterilization, undergo menopause, or take some form of highly effective contraception during and within 12 weeks after treatment; Male patients must undergo surgical sterilization of males, or use highly effective contraceptive methods during the treatment period and within 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1) Esophageal fistula patients; 2) Hypertension that is difficult to control with medication (systolic blood pressure >= 160 mmHg and diastolic blood pressure >= 90 mmHg); 3) Other malignant tumors that have occurred or are currently present within the past 2 years, excluding cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)); 4) Has experienced arterial/venous thrombosis events within the past 3 months, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism; 5) Any research drug or excipient allergy; 6) Untreated chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA exceeding 2000 U/mL, or active hepatitis C virus (HCV) infected patients; 7) There is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), with the following exceptions: vitiligo or recovered childhood asthma/allergy, patients who do not need any intervention after adulthood, autoimmune mediated hypothyroidism treated with a stable dose of thyroid replacement hormone, type I diabetes treated with a stable dose of insulin, and the specific situation shall be evaluated by the investigator. 8) Patients with a history of previous allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or those assessed by other researchers as having an impact on the study treatment; 9) Long term and extensive use of hormones or other immune modulators; 10) There is active infection; 11) Received a live or attenuated vaccine within 30 days prior to the first administration, or planned to receive a live or attenuated vaccine during the study period; 12) Suffering from severe cardiovascular disease: Grade II or above myocardial ischemia or myocardial infarction, or stent implantation surgery within 3 months before enrollment; Control of poor cardiac arrhythmia; According to NYHA standards (Appendix III), grade III-IV heart failure, or left ventricular ejection fraction (LVEF)<50% as indicated by cardiac ultrasound examination; 13) Have a history of interstitial lung disease or uncontrollable systemic disease, including diabetes, acute lung disease, etc; 14) Known to have human immunodeficiency virus (HIV) infection; 15) Any major surgery requiring general anesthesia has been performed within 28 days prior to the first administration; 16) There are basic medical conditions or alcohol/drug abuse or dependence that are unfavorable for drug administration, may affect the interpretation of results, or pose a high risk of treatment complications for patients; 17) Simultaneously participating in another therapeutic clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Objective Response Rate;Disease control rate;R0 resection rate;disease-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactLiang Dai
Beijing Cancer Hospital (Peking University Cancer Hospital and Institute)
Outcome results
None listed