esophageal cancer
Conditions
Interventions
Experimental Group:Sindilizumab in combination with chemotherapy
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to implementing any trial-related procedures; 2. Male or female, age: 18 years; 3. Patients diagnosed with esophageal squamous cell carcinoma after pathological histological examination of primary lesion biopsy; 4. Patients judged to be operable by imaging and esophagoscopy (TNM stage IIA-IIIB); 5. At least one radiologically measurable lesion according to the efficacy evaluation criteria of solid tumors (RECIST 1.1); 6.The patient had not received any previous anti-tumor therapy, including but not limited to surgery, radiotherapy or chemotherapy Immunotherapy, targeted therapy, etc; 7. The ECOG score is 0-1 points; 8. Sufficient organ function, the subjects should meet the following laboratory indicators: 1) Absolute value of neutrophils without using granulocyte colony-stimulating factor in the last 14 days (ANC)=1.5x109/L; 2) 100109 / L in the last 14 days. 3) Hemoglobin> 9 g/dL in the absence of blood transfusion or the use of erythropoietin in the last 14 days. 4) Total bilirubin 1.5 upper limit of normal value (ULN); 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are at 2.5 ULN 6) Blood creatinine 1.5 ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) 60 ml/min; 7) Good coagulation function, defined as international normalized 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 the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled; 9) The myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities as judged by the investigator); 9. For female subjects of childbearing age, a urine or serum pregnancy test within 3 days prior to the first dose of study drug (cycle 1 Day 1, was negative). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. 10. Non-childbearing women were defined as at least 1 year after menopause or undergoing surgical sterilization or hysterectomy; if at risk of conception, all subjects (either male or female) had an annual failure rate of less than 1% for the entire treatment period until 120 days (or 180 days after the last chemotherapy dose) after the last dose of treatment. Note: Hepatitis B subjects who meet the following criteria may also be enrolled: 1) HBV viral load <1000 copies / ml (200 IU / ml) before the first dose, subjects should receive anti-HBV therapy throughout the study chemotherapy treatment to avoid viral reactivation; 2) No prophylactic anti-HBV treatment is required for anti-HBc (+), HBsAg (-), anti-HBs (-), anti-HBs (-) and HBV viral load (-), but close monitoring of viral reactivation is required; 3) Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection); 4) Live vaccine was received within 30 days before the first dose (Cycle 1, Day 1); Note: Acceptance of an inactivated virus vaccine for injection against seasonal influenza is allowed within 30 days prior to the first dose; however, a live attenuated influenza vaccine is not permitted.
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with other malignancies within 5 years before the first dose and not cured (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and / or radical resection of carcinoma in situ); 2.Patients who may have tracheoesophageal fistula or aortic esophageal fistula; 3.Currently participating in interventional clinical study treatment or having received other study drug or study device within 4 weeks prior to the first dose; 4.Anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulus or synergistic inhibition of T cell receptors (e. g., CTLA-4, OX-40, CD137); 5. Have received Chinese patent medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before the first administration; 6. Drug systemic systemic therapy; active autoimmune diseases requiring systemic treatment (e. g., disease-modifying drugs, glucocorticoids, or immunosuppressants) occurred within 2 years prior to the first dose; 7.Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered as systemic therapy; 8.Study receiving systemic corticosteroids (excluding nasal, inhalation, or other routes) or any other form of immunosuppressive therapy within 7 days before the first dose; Note: physiological doses of corticosteroids (10mg / day prednisone or equivalent) are allowed; 9.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10.Those allergic to the study drug cindilizumab and the active ingredients or excipients of the combination chemotherapy drug; 11.Have not fully recovered from toxicity and / or complications due to any intervention (i. e., grade 1 or at baseline, excluding fatigue or alopecia); 12.A known history of human immunodeficiency virus (HIV) infection (i. e., HIV 1 / 2 antibody positive); 13.Untreated active hepatitis B (defined as HBsAg positive and detected HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center); 14.Medical history or disease evidence that may interfere with the trial results, prevent subject participation throughout the study, abnormal treatment or laboratory test values, or other potential risks that the investigator considers render the investigator unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Recurrence free survival;Objective response rate;Overall survival;Adverse event; | — |
Countries
China
Contacts
Public ContactXuewen Yang
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed