esophageal cancer
Conditions
Interventions
Experimental Group :Sintilimab combined with albumin paclitaxel/cisplatin chemotherapy as neoadjuvant chemotherapy before surgery
Sponsors
Friendship Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any testing related processes; 2. Male or female, aged 18 years or above; 3. Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of the primary lesion biopsy; 4. Patients (cT2-4, N1-3M0) who are determined by imaging and esophagoscopy to be operable and require neoadjuvant treatment, stage II-IVA; 5. According to imaging and esophagoscopy, the main body of the patient's tumor is located in the middle and lower esophagus; 6. According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there should be at least one imaging measurable lesion; 7. The patient has not received any anti-tumor treatment 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 is required for the subject to meet the following laboratory indicators: 1) In the past 14 days without the use of granulocyte colony stimulating factor, the absolute value of neutrophils (ANC) = 1.5x109/L. 2) Platelets = 100 without blood transfusion in the past 14 days × 109/L. 3) In the absence of blood transfusion or use of erythropoietin within the past 14 days, hemoglobin>9g/dL; 4) Total bilirubin = 1.5 × Upper limit of normal value (ULN); Or total bilirubin>ULN but direct bilirubin = ULN 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are = 2.5 × ULN (ALT or AST = 5 allowed for patients with liver metastasis) × ULN); 6) Blood creatinine = 1.5 × ULN and creatinine clearance rate (calculated using Cockcroft Fault formula) = 60 ml/min; 7) Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; 10. For female subjects of childbearing age, a urine or serum pregnancy test should be conducted within 3 days before receiving the first study drug administration (day 1 of the first cycle) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non reproductive age women are defined as those who have undergone at least one year of menopause or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all participants (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors diagnosed and not cured within 5 years before the first dose (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma); 2. Preoperative examination suggested that the tumor had the possibility of invading trachea, bronchus or aorta; 3. The current are participating in clinical research and treatment of intrusive, or within 4 weeks before the first dose received study used drugs or other treatments; 4. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137); 5. The first time to give medicine anticancer indications received within 2 weeks before the immunoregulatory effects of proprietary Chinese medicine or drugs (including uct, interferon, interleukin, except for local control chest water use) systemic systemic treatment; 6. For the first time to give medicine 2 years before happened need systemic treatment (for example, using alleviate disease drugs, corticosteroids or immunosuppressants) the sexual activity itself of immune diseases. , thyroid hormone replacement therapy (such as insulin or used for adrenal or pituitary insufficiency of physiologic glucocorticoid, etc.) shall not be regarded as systemic treatment; 7. Is the first study drug delivery within 7 days before is being treated for a systemic corticosteroids (not including the nasal spray, inhalation, or other ways of topical corticosteroids) or any other form of immunosuppressive therapy; Note: Physiologic doses of glucocorticoids (=10 mg per day of prednisone or equivalent) were allowed. 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. This study drugs known letter di allergy to an active ingredients or materials; Have not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade =1 or baseline, excluding fatigue or alopecia); 11. The known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive); 12. Untreated active hepatitis b (defined as HBsAg positive at the same time to detect HBV - DNA copy number is greater than the clinical laboratory's research center upper limit of normal). Note: Subjects with hepatitis B who met the following criteria were also eligible for inclusion: 1) HBV viral load <2000 copies /ml (200 IU/ml) before the first dose, subjects should receive anti-HBV therapy throughout the study chemotherapy drug treatment 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 viral reactivation should be closely monitored 13. Active HCV-infected subjects (HCV-antibody positive with an HCV-RNA level above the lower limit of detection); 14. Before the first dose (1 cycle, day 1) vaccinated live vaccine within 30 days; Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; But not allowed to accept live attenuated influenza vaccine intranasal administration. 15. Pregnancy or lactation women; 16. The presence of any serious or uncontrolled systemic illness, such as: 1) significant rhythm, conduction or morphological abnormalities in resting ECG, such as complete left bundle branch block, = ? de
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Recurrence free survival; | — |
Countries
China
Contacts
Public ContactYong Cui
Director of Department of Thoracic Surgery, Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed