esophageal squamous cell carcinoma (ESCC)
Conditions
Interventions
low-dose radiotherapy group:Radiation therapy: 10 Gy in 2.0 Gy × 5 fractions.
Starting on day 2 after radiation therapy:
Tislelizumab 200 mg on day 1, Q3W
Albumin?bound paclitaxel 125 mg/m2 on days 1 and 8, Q3W
Carboplatin AUC=5 on day 1, Q3W
for a total of 3 cycles.
High-dose radiotherapy group:Radiation therapy: 15 Gy in 3.0 Gy × 5 fractions.
Starting on day 2 after radiation therapy:
Tislelizumab 200 mg on day 1, Q3W
Sponsors
Tangdu Hospital, Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily provided written informed consent. 2. Age between 18 and 75 years (inclusive), male or female. 3. Life expectancy = 3 months. 4. Predicted to achieve R0 resection. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Histologically confirmed, treatment-naïve, locally advanced resectable esophageal squamous cell carcinoma meeting the following criteria: Stage: T1 N1-3 M0 or T2-4a N0-3 M0 (T2 = 3 cm or poorly differentiated) Tumor located below the cervical esophagus and = 5 cm from the cricopharyngeus muscle. 7. No suspected metastatic cervical lymph nodes on neck ultrasound or contrast-enhanced CT; no evidence of distant metastasis on imaging. 8. Presence of measurable tumor lesions. 9. Adequate organ function demonstrated by screening laboratory tests (no blood transfusion or blood component therapy, or granulocyte colony-stimulating factor within 14 days prior to screening): (1)Hematology: Absolute neutrophil count (NEU) = 1.5 × 10?/L (1,500/mm³); Platelet count (PLT) = 100 × 10?/L (100,000/mm³); Hemoglobin = 90 g/L. (2)Liver: Total bilirubin (TBil) = 1.5 × ULN; or direct bilirubin within normal limits in subjects with TBil < 1.5 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN. (3) Renal: Serum creatinine = 1.5 × ULN or calculated creatinine clearance (CrCl) = 60 mL/min (using the Cockcroft-Gault formula). (4) Coagulation: International normalized ratio (INR) = 1.5; prothrombin time (PT) or activated partial thromboplastin time (APTT) = 1.5 × ULN. 10. Males with reproductive potential and females of childbearing potential must use effective contraception (e.g., oral contraceptives, intrauterine device, or barrier method with spermicide) during the study and continue contraception for 6 months after the end of treatment. 11. Good compliance and willingness to complete follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with PD 1/PD L1 inhibitors or other agents targeting T cell receptors (e.g., CTLA 4, OX 40, etc.). 2. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 3. Active or suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. **Exceptions**: Type 1 diabetes mellitus and hypothyroidism controlled by stable dose replacement therapy, and skin diseases not requiring systemic treatment (e.g., psoriasis, vitiligo). 4. History of interstitial lung disease = Grade 2. 5. Systemic corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the first study drug administration. 6. History of immunodeficiency, including other acquired or congenital immunodeficiency diseases, organ transplantation, or prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation. 7. Live vaccine administration within 4 weeks prior to the first study drug administration. 8. Severe cardiovascular or cerebrovascular diseases: (1) Uncontrolled hypertension or pulmonary hypertension; (2) Unstable angina pectoris, or myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months prior to study drug administration; (3) Chronic heart failure with cardiac function = Grade 2 (New York Heart Association [NYHA] classification); (4) Left ventricular ejection fraction (LVEF) 450 msec in males or > 470 msec in females, complete left bundle branch block, third degree atrioventricular block; (6) Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study drug administration. 9. Presence of uncontrolled or severe underlying diseases, including but not limited to active infections requiring systemic antibiotic therapy. 10. Positive human immunodeficiency virus (HIV) antibody test, or active hepatitis B or C infection. The following cases are allowed to participate: (1) Hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, but HBV DNA is below the lower limit of detection (negative) or < 500 IU/mL at the study center, and the investigator excludes active infection based on clinical treatment and manifestations; (2) Hepatitis C antibody positive, but HCV RNA is below the lower limit of detection (negative) at the study center. 11. Known active pulmonary tuberculosis (TB). Patients with suspected active TB must be excluded by chest X ray, sputum examination, and clinical signs and symptoms. 12. History of other active malignant tumors within the past 2 years, except for malignancies with expected cure after adequate treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery). 13. History of psychoactive substance abuse that cannot be abstained from, or history of mental disorders. 14. Pregnant or lactating women. 15. Any other severe acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that, in the investigator’s judgment, may increase the risk associated with study participation or interfe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response (pCR) rate;objective response rate (ORR);R0 resection rate, downstaging rate;downstaging rate; 3-year event-free survival (EFS);3-year overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathological response (MPR) rate;Adverse event;quality of life ; | — |
Countries
China
Contacts
Public ContactXiaolong Yan
Tangdu Hospital, Air Force Medical University
Outcome results
None listed