Esophageal Cancer
Conditions
Interventions
Test group A:Concurrent chemoradiotherapy + chemotherapy combined with immunotherapy + surgery
Test group B:Chemotherapy combined with immunotherapy +concurrent chemoradiotherapy + surgery
Test group C:Concurrent chemoradiotherapy + surgery
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 to 75 years old; 2. Pathologically confirmed thoracic esophageal squamous cell carcinoma; 3. Evaluated as initially resectable locally advanced esophageal squamous cell carcinoma (cT1-3N+M0, cT3N0M0) by endoscopic ultrasound and/or chest CT; 4. ECOG performance score 0-1; 5. At least one measurable lesion according to RECIST 1.1 criteria; 6. Normal major organ and bone marrow function: Blood routine test: Hemoglobin (Hb) >= 90g/L (no blood transfusion within 14 days); Absolute neutrophil count (NEUT) >= 1.5×10^9/L; Platelet (PLT) >= 100×10^9/L; Biochemical test: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 28 g/L; Serum creatinine (Cr) 50µmol/L; Coagulation function test: International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5×ULN (unless the subject is receiving anticoagulant therapy and INR and APTT are within the expected range of anticoagulant therapy); 7. Effective contraceptive measures during the study period; 8. Voluntary participation in this study, signing the informed consent form, and good compliance.
Exclusion criteria
Exclusion criteria: 1. Patients with esophageal squamous cell carcinoma who have received any anti-tumor treatment in the past, including but not limited to chemotherapy, targeted therapy, immunotherapy and radiotherapy, etc. 2. Patients with cervical esophageal cancer. 3. Patients requiring systemic anti-infection treatment. 4. Patients with other primary malignant tumors in addition to esophageal cancer (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ). 5. Patients with existing esophageal perforation or at high risk of esophageal perforation. 6. Patients with severe cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 5 years; as well as patients with other uncontrolled acute or chronic diseases. 7. Patients known to be allergic to any component of the study drugs; patients with a history of severe hypersensitivity reactions to other monoclonal antibodies. 8. Patients known to have mental illness, drug abuse, alcoholism or drug addiction. 9. Pregnant or lactating women. 10. Other situations judged by the investigator as unsuitable for participation in this study, including but not limited to poor patient compliance, inability to tolerate dual-drug chemotherapy, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;disease-free survival;overall survival;Safety;Biomarker; | — |
Countries
China
Contacts
Public ContactYin Li
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed