esophageal cancer
Conditions
Interventions
treatment group:Chemotherapy (albumin paclitaxel + Nedaplatin)
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be eligible for this study, patients must meet all of the following criteria: 1. Sign a written informed consent before implementing any procedures related to the trial; 2. male or female, aged 18 years or above, 75 years or below; 3. Patients diagnosed with esophageal squamous cell carcinoma by primary biopsy and histopathological examination; 4. Patients diagnosed by imaging and esophagoscopy as operable and requiring neoadjuvant therapy (cT2-4, N1-3M0), stage II-IVA; 5. According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there is at least one radiographically measurable lesion; 6. The patient has not received any anti-tumor therapy in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 7. ECOG score 0-1; 8. For adequate organ function, subjects must meet the following laboratory criteria: 1) In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) was =1.5x10^9/L. 2) Platelets =100×10^9/L in the past 14 days without blood transfusion. 3) Hemoglobin >9g/dL in the last 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin =1.5× upper limit of normal (ULN); 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are =2.5×ULN 6) Serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =60 ml/min; 7) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included) 9. Female subjects of reproductive age should receive the first study drug administration (Cycle 1 Day 1) A urine or serum pregnancy test was taken within 3 days prior to the test and the result was negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 10. If there is a risk of pregnancy, all subjects (male or female) should be treated completely Contraception with an annual failure rate of less than 1% was used during treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria are not eligible for admission to this study: 1. Patients diagnosed with other malignancies and not cured within 5 years prior to initial dosing (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Patients at risk of tracheoesophageal fistula or aortoesophageal fistula; 3. Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 4. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 5. Received systemic systemic treatment with proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs within 2 weeks before the first administration; 6. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 7. Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: The use of physiological doses of glucocorticoids (=10 mg/ day of prednisone or equivalent) is permitted; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Patients who are known to be allergic to the active ingredients or excipients of the drug of this study, sindillizumab and combination chemotherapy; 10. Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., = grade 1 or baseline, excluding weakness or hair loss); 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 12. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the group: 1) HBV viral load <1000 copies /ml (200 IU/ml) prior to initial dosing, subjects should receive anti-HBV therapy throughout study chemotherapy therapy to avoid viral reactivation 2) For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required 13. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 14. Received live vaccine within 30 days prior to the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted. 15. Subjects deemed inoperable by physicians. 16. Pregnant or lactating women; 17. The presence of any serious or uncontrolled systemic disease, such as: 1) The resting electrocardiogram has major abnormal rhythm, conduction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Recurrence-free survival;overall survival;Adverse reactions associated with neoadjuvant therapy; | — |
Countries
China
Contacts
Public ContactYang Wenfeng
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed