esophageal cancer
Conditions
Interventions
Tegio 60mg/m2/d, d1-14
Nedaplatin 85 mg/m2, d1, d2, d3
Q3w, 2-4 cycles in total.
Sponsors
shandong cancer hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age 18-75, male or female; (2) Resectable esophageal cancer patients confirmed by histopathology or cytology; (3) Patients with pathological stage of cT1b-cT2N+or cT3-cT4aNany. (4) According to the evaluation standard of solid tumor efficacy (RECIST 1.1), there should be at least one measurable lesion, and the measurable lesion should not have received radiotherapy or other local treatments; (5) ECOG score 0-1; (6) Expected survival time = 12 weeks; (7) Subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with follow-up; (8) The functions of important organs meet the following requirements (no blood components, cell growth factors, leukogenic drugs, platelet promoting drugs, anemia correcting drugs are allowed to be used within 14 days before the first use of the study drug); A Absolute neutrophil count (ANC) = 1.5 * 109/L; B Platelet = 100 * 109/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 times ULN; F Serum creatinine = 1.5 times ULN or creatinine clearance>60mL/min; G Activated partial thromboplastin time (APTT) and international normalized ratio (INR) = 1.5 times ULN. (9) Pre resected tumor tissue is available; (10) Ejection fraction in echocardiography was>50% before treatment; (11) No history of surgical resection;
Exclusion criteria
Exclusion criteria: (1) Distant metastasis or adjacent tissue or organ infiltration, all primary unresectable staging; (2) Recurrent patients; (3) BMI 10mg prednisone equivalent dose per day) or other immunosuppressants for systematic treatment within 2 weeks before the first use of the study drug; E Those who have been vaccinated with anti-tumor vaccine or have been vaccinated with live vaccine within 4 weeks before the first administration of the study drug; F Those who have undergone major surgery or trauma within 4 weeks before the first use of the study drug; (8) Patients with active autoimmune diseases and autoimmune diseases, excluding vitiligo or childhood asthma/allergy that has been cured, who do not need any intervention after adulthood; Autoimmune received hypothyroidism treated with a stable dose of thyroid replacement hormone, and type I diabetes treated with a stable dose of insulin. (9) Have a history of immunodeficiency, including HIV test positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; (10) Subjects have cardiovascular clinical symptoms or diseases that are not well controlled; (11) Serious infection (CTCAE>2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization; The baseline chest imaging examination revealed active pulmonary inflammation, signs and symptoms of infection within 2 weeks before the first use of the study drug, or the need for oral and intravenous antibiotic treatment, except for the prophylactic use of antibiotics. (12) Have a history of interstitial lung disease (excluding radioactive pneumonia not treated with glucocorticoid) and non infectious pneumonia; (13) Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis interference history more than 1 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;Objective Response Rate;event-free survival;overall survival;R0 resection rate; | — |
Countries
China
Contacts
Public ContactWenfeng Yang
shandong cancer hospital
Outcome results
None listed