Esophageal Cancer
Conditions
Interventions
control group:Neoadjuvant chemoradiation
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathological biopsy results showed esophageal squamous cell carcinoma; 2. Sent to have not received systemic and local treatment for esophageal cancer; 3. Aged 18-75 years, both men and women; 4. ECOG score 0-1; 5. Primary tumor located in the chest, if the distance between the tumor center and the gastroesophageal junction is = 100 g/L, white blood cell count >=4.0*10^9/L or neutrophil count >=2.0*10^9/L, Platelet count >=100*10^9/L; (2) Liver: serum total bilirubin level =60ml/min, urea nitrogen 800ml by the surgical expert assessment; (7) Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency;
Exclusion criteria
Exclusion criteria: 1. Previous history of subtotal gastrectomy or surgical contraindications; 2. Unresectable disease before treatment, including cT4b or M1; 3. Any active autoimmune disease or autoimmune history; 4. Well-controlled cardiac clinical symptoms or diseases; 5. Congenital or acquired immune deficiency, or active hepatitis (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.); 6. History of uncontrollable diabetes; 7. Used other drug clinical trials before the first medication; 8. Severe allergic reactions to monoclonal antibodies, paclitaxel, platinum drugs or human albumin allergy; 9. Previous or ongoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy; 10. The patient has other serious diseases that may affect the follow-up and short-term survival at the discretion of the investigator; 11. Pregnant or breastfeeding patients of childbearing age; 12. Patients with the following active infectious diseases, including active pulmonary tuberculosis, hepatitis, known human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year rate of Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year rate of overall survival;pathological complete response rate; | — |
Countries
China
Contacts
Public ContactLi Zhigang
Shanghai Chest Hospital
Outcome results
None listed