esophageal cancer
Conditions
Interventions
experimental group:Sintilimab + chemotherapy
Sponsors
The First Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. It is diagnosed as locally advanced thoracic esophageal cancer by imaging, histopathology or cytology, and the clinical stage is T2N+M0, T3N0-1M0, T4aN0-1M0. Radical treatment of esophageal cancer is required according to the routine diagnosis and treatment process by the doctor. Surgery, patients with esophageal cancer who need neoadjuvant treatment before surgery; 3. Physical fitness ECOG PS score: 0-1 points; 4. Estimated survival period >= 6 months; 5. There are no contraindications to the operation of various organ functions before operation; 6. Laboratory inspection indicators meet the following requirements: (1) Bone marrow function: hemoglobin (Hb) >=90g/L; white blood cell count (WBC) >= lower limit of normal value; absolute neutrophil value (ANC) >= 1.5x10^9 /L; platelet count >= 100x10^9 / L; (2) Renal function: Cr = 55 ml/min; (3) Liver function: total bilirubin 38 degrees C; 12. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the plan.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed in the past 5 years; 2. There are distant organ transfers; 3. Suffer from any active autoimmune disease or history of autoimmune disease; 4. Suffer from uncontrolled clinical symptoms or diseases of the heart; 5. Active infection or fever (except for clear tumor fever); 6. History or evidence of interstitial lung disease or active non-infectious pneumonia; 7. Patients with immunodeficiency and active hepatitis; 8. Those who have received PD-1 or PD-L1 antibody therapy in the past; 9. Those who are allergic to any of the drugs in this plan; 10. Those who used immunosuppressive drugs or corticosteroids >10mg/day with a curative dose of prednisone within 14 days before enrollment; 11. Those who have received radiotherapy, chemotherapy, targeted therapy or immunotherapy within 4 weeks before enrollment; 12. Women during pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;R0;Pathological downgrade rate;DFS;Safety; | — |
Countries
China
Contacts
Public ContactHaiping Jiang
The First Affiliated Hospital of Medical College of Zhejiang University
Outcome results
None listed