esophageal cancer
Conditions
Interventions
experimental group:anti-PD-1 antibodies + Chemoradiotherapy
Sponsors
Wang Wei
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed patients with locally advanced thoracic esophageal squamous cell carcinoma should undergo radical resection of esophageal cancer according to routine diagnostic and therapeutic procedures and neoadjuvant radiotherapy and chemotherapy before operation. 2. Aged 20-75 years, gender unlimited; 3. According to RECIST 1.1, there is at least one measurable lesion, and the lesion has not received radiotherapy . 4. Volunteered, signed informed consent, good compliance; 5. It can provide the clinical data needed to complete the research. 6. ECOG was 0 - 1. 7. Survival is expected to exceed 12 weeks. 8. Organ function level must meet the following requirements: Bone marrow: absolute neutrophil count (ANC) >= 1.5 *10^9/L, platelet (>= 100 *10^9/L), hemoglobin (>= 9 g/dL). Liver: bilirubin = 45 mL/min) was calculated (using standard Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed in the past five years; 2. distant organ metastasis; 3. Have any history of active autoimmune disease or autoimmune disease; 4. suffering from uncontrolled cardiac symptoms or diseases; 5. Active infection or fever (except clear cancer fever); 6. History or evidence of interstitial lung disease or active noninfectious pneumonia; 7. Immune deficiency and active hepatitis; 8. Those who have received anti-PD-1 or anti-PD-L1 therapy in the past; 9. Any drug allergic patients in this scheme; 10. Those who used immunosuppressive drugs or corticosteroids > 10mg/prednisone within 14 days before admission; 11. Those who received radiotherapy, chemotherapy, targeted therapy or immunotherapy within 4 weeks before admission; 12. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;The relationship between biological markers in esophageal cancer tissues and/or blood (such as PD-L1, MSI, immune cell subsets, etc.) and the efficacy of anti-PD-1 antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;3-year survival rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactWang Wei
Nanfang Hospital of Southern Medical University
Outcome results
None listed