Esophageal Cancer
Conditions
Interventions
Experimental group:Adebrelimab combined with neoadjuvant chemotherapy
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Squamous Esophageal Cancer diagnosed by histopathology; 2. Thoracic Esophageal Cancer assessed by CT/PET-CT and clinically staged as cT1b to cT2N+ or cT3 to cT4a any N (according to AJCC 8th edition); 3. age 18-75 years old, male or female; 4. ECOG PS 0-1; 5. Measurable tumor lesions or non-measurable lesions that can be evaluated; 6. Not having received any previous antitumor therapy for esophageal cancer, including radiotherapy, chemotherapy, or surgery; 7. Planning to undergo surgery after completion of neoadjuvant therapy; 8. Have normal or mild to moderate abnormal lung function (VC%>60%, FEV1>1.2L, FEV1%>40%, DLco>40%) and can tolerate esophagectomy for esophageal cancer; 9. No contraindications to surgery 10. Function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors within 14 days) - Normal bone marrow reserve function - Normal renal function with serum creatinine (SCr) = 1.5 times upper limit of normal (ULN) or creatinine clearance = 60 ml/min (Cockcroft-Gault formula); - Normal liver function with total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN); and an albumin transaminase (AST) or alanine transaminase (ALT) level =2.5 times the upper limit of normal (ULN); - Normal coagulation with International Normalized Ratio (INR) = 1.5 times the Upper Limit of Normal (ULN) and Activated Partial Thromboplastin Time (APTT) = 1.5 times the Upper Limit of Normal (ULN). 11. Patients with potential childbearing potential will be required to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms) during and for 6 months after the end of the study period; must have had a negative serum HCG or urine HCG test within 72 h prior to study entry; and must not be breastfeeding. 12. Patients will voluntarily enroll in the study, sign an informed consent form, and have good compliance with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Poor nutritional status, BMI 10 mg/day prednisone or equivalent) within 2 weeks prior to first use of study drug; inhaled or topical steroids and adrenocorticotropic hormone replacement at doses >10 mg/day prednisone or equivalent are permissible in the absence of active autoimmune disease; c) Received a live attenuated vaccine within 4 weeks prior to first use of study drug; d) Major surgery or severe trauma within 4 weeks prior to first use of study drug; 4. Any active autoimmune disease or history of autoimmune disease including, but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for enrollment after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have been in complete remission and do not require any intervention in adulthood may be considered for enrollment, except that patients requiring bronchial Medical intervention with bronchodilators may not be included; 5. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation; 6. The presence of clinically uncontrolled cardiac conditions or diseases including, but not limited to, conditions such as (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias that are not clinically intervened with or that remain poorly controlled after clinical intervention 7. A serious infection (CTCAE grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious co-morbidities within 4 weeks prior to the first use of study drug; except for prophylactic antibiotic use if baseline chest imaging suggests the presence of active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of study drug, or the need for oral or intravenous antibiotic therapy 8. The presence of active tuberculosis infection by history or CT scan, or a history of active tuberculosis infection within 1 year prior to enrollment, or a history of active tuberculosis infection more than 1 year ago without regular treatment 9. Presence of active hepatitis B HBV DNA = 2000 IU/mL or 104 copies/mL hepatitis C (hepatitis C antibody positive and HCV RNA above the lower limit of detection by analytical methods); 10. A previous diagnosis of another malignancy within 5 years prior to the first dose of study drug, except for malignancies with a low risk of metastasis or risk of death (5-year survival > 90%), such as adequately treated basal cell carcinoma of the skin or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix, ma
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| R0 Removal rate;Main pathological remission rate;Disease-free survival, DFS;Objective response rate, ORR;Overall survival, OS; | — |
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactWu Chao
Chinese PLA General Hospital
Outcome results
None listed