Esophageal cancer
Conditions
Interventions
Experimental group:Carrelizumab + Albumin Paclitaxel + Carboplatin + Radiotherapy
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent; 2. Aged 18 to 75 years, gender is not limited; 3. Cytological or histological confirmed esophageal squamous cell carcinoma; 4. No previous local treatment for primary esophageal tumors, including surgery and radiation therapy; 5. Clinical staging: cT2-4a, N0-3, M0 (AJCC/UICC Staging of Esophageal Cancer (Eighth Edition)); 6. The primary tumor can be evaluated; 7. No distant organ metastasis; 8. PS score 0-1 points; 9. Expected survival period >= 6 months; 10. The function of major organs is normal, that is, the following criteria are met: (1) Routine blood test: 1) HBG>=90g/L; 2) ANC>=1.5x10^9/L; 3) PLT >=80x10^9/L; (2) Biochemical examination: 1) ALB>=30g/L; 2) ALT and AST=60ml/min. 11. Pulmonary function: FEV1/FVC>=70%, FEV1>=50% normal value, the percentage of DLCO (lung diffusing function) measured value and predicted value>80%. 12. Women of childbearing age must be pregnant within 7 days before starting treatment and the result is negative; 13. All enrolled patients should take adequate contraceptive measures throughout the treatment period and 4 weeks after the end of the treatment; 14. No serious hematopoietic function, abnormal cardiac function and immune deficiency; 15. No esophageal perforation and active esophageal bleeding, no invasion of trachea and thoracic large vessels.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or has autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma has been completely resolved in childhood, without any intervention in adulthood can be included; patients with asthma requiring bronchodilator medical intervention can not be included); 2. The patient is using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other equivalent therapeutic hormone), and continues to use it within 2 weeks before enrollment; 3. Previous treatment with EGFR monoclonal antibody or EGFR tyrosine kinase inhibitor; 4. Patients with any severe and/or uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); myocardial ischemia or myocardial infarction, arrhythmia above grade I (including QT interval >=480ms) and grade I cardiac insufficiency; Active or uncontrolled serious infection; Liver disease such as decompensated liver disease, active hepatitis B (HBV-DNA >= 104 copies/ml or 2000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); 5. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study; 6. Pregnant or lactating women; Patients with other malignant tumors within 7.5 years (except for basal cell carcinoma of the skin and carcinoma in situ of the cervix that have been cured); 8. Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 9. Patients who have participated in clinical trials of other drugs within four weeks; 10. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study; 11. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactDong Qian
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed