Esophagus cancer
Conditions
Interventions
Experimental group: Camrelizumab combined with Nedaplatin and Tegafur
Sponsors
The Second People's Hospital of Dezhou City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged of patients ranged from 18-75 years; 2. The esophageal squamous cell carcinoma patient who was initial diagnosed as stage T2, 3N0-2M0 resectable esophageal cancer by histology or cytology. Patients who was unable to obtain histology or cytologist, can provide clinical diagnosis by medical history, laboratory examination and imaging examination (such as CT, MRI, PET / CT); 3. After surgical resection, R1 resection or R2 resection were achieved, with indications of additional treatment (chemoradiotherapy, surgery) : (1) submucosal infiltration depth >=200um; Lymphatic vascular infiltration positive; (2) poorly differentiated or undifferentiated carcinoma; (3) Vertical cutting edge positive. The doctor considers the patient's general condition and will comprehensively; 4. ECOG PS score within 1 week before entry: 0-1 points; 5. Expected survival time >=3 months; 6. The thoracic surgeon judges that patients can tolerate the operation; 7. If the functions of main organs are normal, patients need to meet the following hematological indicators: (1) The blood test standard must be met (without blood transfusion and blood products within 14 days) ANC>=1.5x10^9/L; PLT>=60x10^9/L; (2) The biochemical inspection must meet the following standards: TBIL 45 ml / min (Cockcroft-Gault formula); 8. Women of childbearing age must have a negative blood pregnancy test within 7 days before enrollment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last study drug administration; 9. The subject who has full civil capacity to sign informed consent with good compliance, participate in the study voluntarily and able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients received anti-PD-1, anti-PD-L1, anti-CD137 or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies (including ipilimumab or any other antibody or drug specifically targeting the co-stimulation or checkpoint pathway of T cells); 2. Serious interference (CTC AE> level 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging examination suggested the presence of active pulmonary inflammation, the presence of signs and symptoms of infection in the 2 weeks prior to initial use of the study drug (fever of unknown origin >38.5?), or the need for oral or intravenous antibiotic treatment. 3. A history of autoimmune diseases requiring systemic treatment (except for insulin or thyroid replacement therapy); 4. Patients with congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; 5. History of immunodeficiency disease (such as immunoglobulin deficiency or leukocyte spectrum depletion disease); 6. Previous history of malignancy in the past 5 years, excluding treated basal cell carcinoma of the skin or squamous cell carcinoma; 7. Immunosuppressive drugs should be used, including but not limited to glucocorticoids (dose >10mg/ day prednisone or other therapeutic hormone), ivermox, sirolimus, and disease-relieving anti-rheumatic drugs (DMARDS); 8. Patients with clinical symptoms of ascites, pleural effusion or pericardial effusion who require therapeutic puncture or drainage, such as those with pleural effusion or pericardial effusion, who are observed to be stable for at least 2 weeks after drainage and before the first study drug is first used, may be included in the study; 9. Hypersensitivity to docetaxel, nedaplatin and camrelizumab of the research products; 10. The patient with III to IV level cardiac insufficiency according to NYHA standard, or whose Color Doppler examination of heart revealed left ventricular ejection fraction (LVEF) =++, it was confirmed that 24-hour urinary protein quantity >=1.0g; 12. Patients who is known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction (INR>1.5×ULN, APTT>1.5×ULN), thrombocytopenia, hypersplenism, etc.) or hyperactive or venous thrombotic events in the past 6 months (till to the first administration of SHR-1210); 13. Persons with a history of substance abuse and unable to quit or with mental disorders; 14. According to the judgment of the investigator, the patient with serious risk to the safety for the patient or concomitant disease which may affect the completion of the study; 15. Patients who are participating in other clinical trials or whose completion time of other clinical trials is less than 4 weeks; 16. The researchers considered inappropriate to include.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP;PFS;OS; | — |
Countries
China
Contacts
Public ContactChuntang Wang
Department of Thoracic Surgery, the Second People's Hospital of Dezhou City
Outcome results
None listed