Esophageal squamous cell carcinoma
Conditions
Interventions
Case series:Immunotherapy and chemotherapy
Sponsors
The Second People's Hospital of Jiaozuo City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients eligible for this study must meet all of the following criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Male or female, aged 18 or above, 75 years or below; 3. Patients who have been diagnosed with esophageal squamous cell carcinoma after biopsy of the primary tumor; 4. Patients who are judged to be operable by imaging and esophagoscopy and need neoadjuvant treatment (cT2-4, N1-3M0), stage II-IVA; 5. Through imaging and esophagoscopy, it is determined that the main body of the patient's tumor is located in the thoracic esophagus; 6. According to the evaluation criteria for the efficacy of solid tumors (RECIST Version 1.1), there is at least one imaging measurable lesion; 7. The patient has not received any anti-tumor therapy in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 8. ECOG score 0-1 points; 9. Sufficient organ function, subjects need to meet the following laboratory indicators: 1) The absolute value of neutrophils (ANC) = 1.5x109/L without using granulocyte colony stimulating factor in the past 14 days. 2) In the case of no blood transfusion in the past 14 days, platelets >=100x10^9/L; 3) In the past 14 days without blood transfusion or erythropoietin, hemoglobin>9g/dL; 4) Total bilirubin=60 ml/min; 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; 9) The myocardial enzyme spectrum is within the normal range (if the investigator comprehensively judges that the simple laboratory abnormality is not clinically significant, it is also allowed to be included); 10. For female subjects of childbearing age, they should receive a urine or serum pregnancy test and the result is negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy; If there is a risk of pregnancy, all subjects (whether male or female) must have an annual failure rate of less than 1 during the entire treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration) 1% Contraceptive measures.
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria cannot be selected for this study: 1. Patients who have been diagnosed with other malignant tumors within 5 years before the first administration and have not been cured (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically excised carcinoma in situ); 2. Patients who may have tracheoesophageal fistula or aortic esophageal fistula; 3. Are currently participating in interventional clinical research treatment, or have received other research drugs or used research devices within 4 weeks before the first administration; 4. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug; 5. Received Chinese patent medicine with anti-tumor indications or systemic systemic treatment with immunomodulatory drugs within 2 weeks before the first administration; 6. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 7. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiological doses of glucocorticoids (=10 mg/day prednisone or equivalent drugs) is allowed; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Those who are known to be allergic to the study drug Sintilimab and the active ingredients or excipients of the combined chemotherapy drugs; 10. Before starting treatment, have not fully recovered from the toxicity and/or complications caused by any intervention (ie, = Grade 1 or reached baseline, excluding fatigue or hair loss); 11. Known human immunodeficiency virus (HIV) infection history (ie HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of normal value of the laboratory department of the research center); Note: Hepatitis B subjects who meet the following criteria can also be included in the group: 1) HBV viral load <1000 copies/ml (200 IU/ml) before the first administration, subjects should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation 2) Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive preventive anti-HBV treatment, but need to closely monitor virus reactivation 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level is higher than the lower limit of detection); 14. Live vaccine has been vaccinated within 30 days before the first dose (cycle 1, day 1); Note: It is allowed to receive the inactivated virus vaccine for seasonal influenza within 30 days before the first administration; however, it is not allowed to receive the live attenuated influenza vaccine for intranasal administration. 15. Pregnant or lactating women; 16. There are any serious or unco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactJincheng Guo
The Second People's Hospital of Jiaozuo City
Outcome results
None listed