Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Neoadjuvant low-dose radiotherapy (4Gy/2f) combined with chemotherapy and immunotherapy group:Neoadjuvant low-dose radiotherapy (4Gy/2f) with nab-paclitaxel/carboplatin and tislelizumab, administered
Neoadjuvant low-dose radiotherapy (8Gy/4f) combined with chemotherapy and immunotherapy group:Neoadjuvant low-dose radiotherapy (8 Gy/4 f) with nab-paclitaxel/carboplatin and tislelizumab, administere
Neoadjuvant low-dose radiotherapy (6Gy/3f) combined with chemotherapy and immunotherapy group:Neoadjuvant low-dose radiotherapy (6Gy/3f) with nab-paclitaxel/carboplatin and tislelizumab, administered
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically (pathologically) confirmed thoracic esophageal squamous cell carcinoma with a clinical stage of: cT1b-cT2 N1-2 M0 or cT3-cT4a N0-2 M0 (according to the AJCC/UICC 8th edition staging system for esophageal cancer); 2. Eligible for R0 radical resection; 3. ECOG performance status of 0-1; 4. Participants aged between 18 and 75 years of age; 5. Adequate organ and bone marrow function without ongoing transfusion support or growth factor administration, as defined by: Hemoglobin (HGB) >= 9.0 g/dL Absolute Neutrophil Count (ANC) >= 1.5 × 10^?/L Platelet (PLT) count >= 100 × 10^?/L White Blood Cell (WBC) count >= 3.5 × 10^?/L; 6. No severe ventilatory dysfunction or acute cardiac failure as confirmed by a radiation oncologist. Pulmonary function must meet the following criteria: FEV1/FVC >= 70%, FEV1 >= 50% of the predicted value, and DLCO > 80% of the predicted value. 7. Adequate hepatic function as defined by: Total Bilirubin (TBIL) = 3.0 g/dL; 8. Adequate renal function defined as a serum creatinine level = 60 mL/min. The CrCl should be determined using the Cockcroft-Gault formula: For Males: CrCl (mL/min) = (140 - Age) × Weight (kg) / (72 × Serum Creatinine (mg/dL)) For Females: CrCl (mL/min) = (140 - Age) × Weight (kg) × 0.85 / (72 × Serum Creatinine (mg/dL)); 9. Participants must voluntarily participate in the study, provide written informed consent, and be willing and able to comply with all scheduled visits and procedures as outlined in the protocol. 10. With a life expectancy of greater than 6 months; 11. Patients who are candidates for and have provided consent to undergo surgery, radiochemotherapy, and immunotherapy; 12. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiating treatment. All participants, regardless of gender, must be willing to use a highly effective method of contraception throughout the trial and for at least 8 weeks after the last dose of the study drug; 13. Absence of esophageal perforation, active esophageal bleeding, and invasion of the trachea or major thoracic blood vessels, as confirmed by radiographic and/or endoscopic evaluation; 14. Presence of at least one radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
Exclusion criteria
Exclusion criteria: 1. Presence of a contraindication to the immunotherapy or chemotherapy specified in the study protocol; 2. Any prior therapy for esophageal squamous cell carcinoma (ESCC), including but not limited to: investigational agents, chemotherapy, radiotherapy, or any anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies, or any other antibody or drug targeting T-cell co-stimulatory or immune checkpoint pathways; 3. History of a fistula caused by primary tumor infiltration; 4. Patients deemed by the investigator to be at high risk for fistula formation or showing signs of perforation; 5. No use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days prior to the first dose, with the exception of: physiologic replacement doses (= second-degree AV block, ventricular arrhythmia, or atrial fibrillation); or (2) clinical cardiac diseases such as unstable angina, congestive heart failure, or chronic heart failure meeting NYHA class >= II;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1/2 year event-free survival;R0 rate;Major pathological response;Overall Response Rate;Tumor Regression Grade;post-neoadjuvant pathological staging (ypTNM); | — |
Countries
China
Contacts
Public ContactYong Yuan
West China Hospital of Sichuan University
Outcome results
None listed