esophageal cancer
Conditions
Interventions
Intervention group:sintilimab
Sponsors
Beijing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged >=18 years old; 3. ECOG PS 0-1; 4. Patients with thoracic esophageal squamous cell carcinoma confirmed by histology or cytology. If neoadjuvant therapy is received before surgery, R0 resection will be achieved, and there is pathological remnant (ypT1-4a or ypN+) after surgery; or, if neoadjuvant treatment has not been performed Treatment of patients undergoing direct surgery, those who have achieved R0 resection and the postoperative pathological stage is pT3-4 or pN+ (AJCC eighth edition); 5. After radical surgery, within 4 weeks of signing informed or first treatment, imaging confirmed no evidence of tumor progression or recurrence; 6. The time between the first administration and the radical operation is not less than 1 month and not more than 3 months; 7. The investigator judges that the patient has recovered from radical surgery and can tolerate the study drug treatment; 8. Sufficient organ function; 9. For female subjects of childbearing age, a urine or serum pregnancy test and the result should be 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; 10. If there is a risk of conception, all subjects (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% during the entire treatment period until 120 days after the last study drug administration of the treatment; 11. Expected survival >= 6 months.
Exclusion criteria
Exclusion criteria: 1. The distance between the upper edge of the tumor and the cricopharyngeal muscle is less than 5cm; 2. Patients whose pathological lymph nodes cannot be assessed after surgery (ypNx or pNx); 3. Diagnosis of other malignant diseases other than esophageal cancer within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous epithelial carcinoma, and/or radically excised carcinoma in situ); 4. Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration; 5. 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; 6. Received systemic systemic treatment with anti-tumor indications Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration; 7. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 8. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled 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 ( 3 months); 11. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. Those who are known to be allergic to the active ingredients or excipients of Sintilimab; 13. Before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (ie, <= Grade 1 or reached baseline, excluding fatigue or hair loss); 14. Known human immunodeficiency virus (HIV) infection history (ie HIV 1/2 antibody positive); 15. 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 the normal value of the laboratory department of the research center).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate;Recurrence-free survival;2 year overall survival rate;Life Quality (EQ-5D-3L); | — |
Countries
China
Contacts
Public ContactWu Nan
Beijing University Cancer Hospital
Outcome results
None listed