esophageal cancer
Conditions
Sponsors
Tengzhou Central People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 75 years old, regardless of gender; (2) Patients with resectable esophageal cancer confirmed by pathological histology or cytology Person; (3) Patients with pathological staging of cT1b-cT2N+or cT3-cT4aNany. (4) According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), at least A measurable lesion that has not undergone local treatment such as radiotherapy; (5) ECOG score 0-1 points; (6) Expected survival time = 12 weeks; (7) Patients voluntarily participate in this study, sign an informed consent form, and comply Okay, cooperate with follow-up; (8) The function of important organs meets the following requirements (first use of study drug) No blood components, cell growth factors, or whitening agents are allowed to be used within the first 14 days Platelet boosting drugs, anemia correcting drugs); a Absolute neutrophil count (ANC) = 1.5 * 10^9/L; b Platelet = 100 * 10^9/L; c Hemoglobin = 10g/dL; d Serum albumin = 2.8g/dL; e Total bilirubin = 1.5 times ULN, ALT, AST, and/or AKP = 2.5 ULN; f Serum creatinine = 1.5 times ULN or creatinine clearance rate>60mL/min; g Activation partial thromboplastin time (APTT) and international standardized ratio (INR) = 1.5 ULN. (9) Pre resection of tumor tissue is available; (10) Before the start of treatment, the ejection fraction on the echocardiography was greater than 50%; (11) No history of surgical resection;
Exclusion criteria
Exclusion criteria: If the patient meets any of the following conditions, they will not be allowed to enter this study. (1) Distant metastasis or infiltration of adjacent tissues or organs, all primary unresectable staging; (2) Recurrent patients; (3) BMI10mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks prior to the first use of the study drug; Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the investigational drug; Individuals who have undergone major surgery or trauma within 4 weeks prior to the first use of the investigational drug; (8) Patients with active autoimmune diseases or a history of autoimmune diseases, excluding vitiligo or recovered childhood asthma/allergies, who do not require any intervention in adulthood; Thyroid hypofunction received by autoimmunity was treated with thyroid replacement hormone at a stable dose, and type I diabetes was treated with insulin at a stable dose. (9) Having a history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation and allogeneic bone marrow transplantation; (10) Subjects with uncontrolled cardiovascular clinical symptoms or diseases; (11) Serious infections (CTCAE>level 2) occurred 4 weeks prior to the first use of the investigational drug, such as severe pneumonia, bacteremia, and infection complications that require hospitalization; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral and intravenous antibiotic treatment, excluding prophylactic use of antibiotics. (12) A history of interstitial lung disease (excluding radiation pneumonia that has not been treated with steroids) and a history of non infectious pneumonia; (13) Patients with active pulmonary tuberculosis infection detected through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within one year before enrollment, or patients with a history of active pulmonary tuberculosis interference disease more than one year ago but without formal treatment; (14) Peripheral neuropathy>NCI Grad II (15) Pregnant or lactating women;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological remission rate;R0 resection rate;Objective response rate;Event free survival;overall-survival;safety; | — |
Countries
china
Contacts
Public ContactHong Zhao
Tengzhou Central People's Hospital
Outcome results
None listed