Esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:Adbelizumab combined with concurrent chemoradiotherapy
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent, have good compliance, and cooperate with follow-up; 2, age =18 years old and = 75 years old; 3, ECOG score 0~1 points; 4. Expected survival =12 weeks; 5. Histological or pathological evidence of resectable thoracic esophageal squamous cell carcinoma with clinical stage T2 N+ M0 or T3-4a anyN M0 (AJCC 8 th); 6. Did not receive any anti-tumor therapy before surgery; 7. The patient has at least one measurable lesion (according to RECIST 1.1 criteria); 8, the main organ function is normal, that is, meet the following standards: (1) The standard of blood routine examination should be met (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct) : A. Hemoglobin (Hb) = 90 g/L; B. Neutrophil count (ANC) = 1.5 × 109/L; C. Platelet count (PLT) = 100 ×109/L; (2) Biochemical examination shall meet the following standards: A. Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); D. Routine urine test results showed urinary protein (UPRO) 1.5 ×ULN without clinical or imaging evidence of pancreatitis can be included in the group); Amylase =1.5 × ULN (if amylase >1.5 × ULN has no clinical or imaging evidence of pancreatitis, it can be included in the group); alkaline phosphatase (ALP) =2.5ULN. (9) Women of reproductive age should agree to use effective contraception during the study period and for 6 months after the end of the study; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period·
Exclusion criteria
Exclusion criteria: 1. Allergic to therapeutic drugs; 2. The patient has received or is receiving other chemotherapy, radiation, immunotherapy, or targeted therapy. 3. Patients whose imaging shows that the tumor has invaded important blood vessels or who are judged by the investigators to be highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 4 or 5 years after the subject has had or co-developed other malignancies requiring active treatment (with the exception of those who have been adequately treated, such as expected 5-year survival >90% basal cell or squamous cell skin cancer, cervical carcinoma in situ, and breast cancer in situ); 5, active autoimmune disease or immune deficiency, or a history of the following, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitaritis, vasculitis, nephritis, etc.) shall not be included. Hiv-positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, allogeneic hematopoietic stem cell transplantation were not included. Exceptions include: Patients with a history of autoimmune hypothyroidism who receive thyroid hormone replacement therapy may be included in the study. Patients with type 1 diabetes whose blood sugar is under control after treatment with an insulin administration regimen may participate in this study. 6. Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormones) and continue to use within 2 weeks before enrollment; 7. Patients receiving systemic treatment with excessive doses of antibiotics within the previous 2 weeks; 8. Patients with excessive arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis and pulmonary embolism, occurred within 6 months before the first administration; 9. Patients with MRI contraindications; 10. Gastrointestinal diseases or conditions that the investigator determines may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectosed gastrointestinal tumors, or other conditions that the investigator determines may cause gastrointestinal bleeding or perforation, Have multiple factors that affect oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 11. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) Grade = 2; Ventricular arrhythmias requiring medical treatment (including QTc interval = 450 ms in men and = 470 ms in women); Left ventricular ejection fraction (LVEF) 38.5? before first administration; 13. Pleural effusion, pericardial effusion or ascites accompanied by clinical symptoms and judged by researchers to require frequent drainage; 14, cirrhosis, active hepatitis; Hepatitis B reference:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological significant response rate;R0 removal rate;Lymph node descending rate;Disease-free survival;Overall survival;The annual DFS rate;1 year OS rate;security;Exploratory end point: MRI prediction of efficacy of neoadjuvant chemoradiotherapy combined with immunotherapy for esophageal cancer.(YNMT)· ; | — |
Countries
China
Contacts
Public ContactChengcheng Fan; Guanghui Liang
Henan Cancer Hospital
Outcome results
None listed