Esophageal squamous cell carcinoma
Conditions
Interventions
Pembrolizumab combined with neoadjuvant chemotherapy group:Pembrolizumab combined with neoadjuvant chemotherapy
Pembrolizumab combined with neoadjuvant radiotherapy group:Pembrolizumab combined with neoadjuvant radiotherapy
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up; 2.Aged 18 to 75 years; 3.ECOG score 0~1 points; 4.Patients with esophageal squamous cell carcinoma diagnosed by pathology (histology or cytology); 5.According to the eighth edition of clinical tumor TNM staging, the subject is resectable cT1b-3N1-3M0 or T3N0M0; 6.With measurable lesions (according to the RECIST 1.1 standard, CT scan of tumor lesions with long diameter >=10mm, lymph node lesions with CT scan short diameter >=15mm); 7.Patients who were diagnosed as esophageal squamous cell carcinoma for the first time before enrollment, and had not undergone radiotherapy, chemotherapy, immunization, surgery, or targeted therapy; 8.Able to eat a liquid diet or above, no signs of esophageal perforation or esophageal ulcers exist, and can tolerate surgery; 9.The main organs are functioning normally, that is, they meet the following standards: (1)Routine blood examination must comply with (no blood transfusion, no hematopoietic factors and no medication correction within 14 days): ANC>=1.5x10^9/L; PLT>=100x10^9; HB>=90g/L; (2)The biochemical examination must meet the following standards: TBIL=50mL/min (Cockcroft-Gault formula); ALB>=30g /L; (3)The coagulation function must meet: INR 60%; FEV1> 1.2 L, FEV1%> 40%; DLco> 40%.
Exclusion criteria
Exclusion criteria: 1.Suffer from any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, thyroid Hyperfunction, hypothyroidism (can be included after hormone replacement therapy); patients with vitiligo or childhood asthma that have been completely relieved and do not require any intervention after adults can be included, and patients who require medical intervention with bronchodilators cannot be included; 2.People with congenital or acquired immune deficiencies, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C, or combined hepatitis B and hepatitis C co-infection; 3.Immunosuppressive drugs have been used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (ie not more than 10mg/day prednisone or its equivalent ); 4.The weight loss of the patient was >=10% within 6 months before enrollment, or BMI=140mmHg or diastolic blood pressure >=90mmHg, despite the best medical treatment); newly diagnosed angina within 3 months before screening or myocardial infarction occurred within 6 months before screening; Arrhythmia (including QTcF: male >=450ms, female >=470ms) requires long-term use of antiarrhythmic drugs and New York Heart Association grade >= Grade II cardiac insufficiency; 8.Those with a history of severe lung or heart disease; 9.Severe infection (e.g. intravenous infusion of antibiotics, antifungal or antiviral drugs is required) within 4 weeks before the first administration, or unexplained fever >38.5? during the screening period/before the first administration; 10.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11.Pregnant or breast-feeding women; those with fertility who are unwilling or unable to take effective contraceptive measures; 12.Known to have allergic reactions, hypersensitivity reactions or intolerances to test drugs and their excipients; 13.Subjects who are participating in other clinical studies or whose first medication is less than 4 weeks from the end of the previous clinical study (last medication), or the study drug's 5 half-lives; 14.The subject is known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse; 15.The researcher believes that there are any conditions that may harm the subject or cause the subject to fail to meet or perform the research requirements; 16.After neoadjuvant treatment, the patient cannot tolerate surgery or is not suitable for surgery due to disease progression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease-free survival;Overall survival;Quality of life;Treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactFu Junke
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed