Esophagus cancer
Conditions
Interventions
Single-arm Group (ESO-Nanjing17):Salvage concurrent chemoradiotherapy (radiotherapy 50.4Gy/28Fx, combined with TC weekly or TC every three weeks chemotherapy), followed by immune and anti-angiogenic m
Sponsors
Jiangsu Cancer Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign an informed consent form; 2. Be between 18 and 80 years of age; 3. Develop regional lymph node metastasis 6 months after curative resection (confirmed by cytology, pathology, or PET-CT imaging); 4. Have a postoperative pathological diagnosis of esophageal squamous cell carcinoma, with lymph node dissection performed during surgery (No specific requirement regarding the number of lymph nodes removed, as this may vary by the level of expertise in each thoracic surgery department); 5. No history of radiotherapy before or after radical esophageal cancer surgery; 6. No severe abnormalities in hematopoietic function, cardiac, pulmonary, hepatic, or renal function, or immunodeficiency; 7. Normal organ and bone marrow function, defined as follows: white blood cell count >= 4,000/µL, hemoglobin >= 9 g/dL (without blood transfusion), neutrophil count >= 2,100/µL, platelet count >= 100,000/µL, total bilirubin 3 months; No primary tumors in other sites prior to treatment, or primary tumors in other sites that have been controlled for more than 5 years;
Exclusion criteria
Exclusion criteria: 1. Complete esophageal obstruction preventing the intake of even liquid foods; deep esophageal ulcers, perforations, or hematemesis; 2. A second primary tumor (excluding cured non-malignant melanoma of the skin, papillary thyroid carcinoma, stage I seminoma, cervical carcinoma in situ, or other "curable" tumors with at least 3 years of disease-free survival following treatment); 3. Use of other investigational drugs within 30 days prior to randomization, or concurrent participation in other clinical trials; 4. Substance abuse (e.g., drug addiction) or chronic alcoholism; 5. Human immunodeficiency virus (HIV) infection; 6. Active hepatitis B (HBV-DNA >= 104 copies/mL), active hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection), or active tuberculosis; 7. Presence of any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.), and who have used immunosuppressants within 28 days prior to randomization (Note: Patients with hypothyroidism may be included if hormone replacement therapy has been stable for >=4 weeks and TSH/FT4 levels are within the normal range); 8. Uncontrolled clinical cardiac symptoms or diseases, including: (1) NYHA Class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 9. Uncontrolled epileptic seizures, or loss of mental capacity due to psychosis; 10. History of severe allergies or hypersensitivity, or allergy to macromolecular protein preparations, adebelizumab, or any component of the formulation; 11. Active infection, or unexplained fever >38.5°C occurring within 2 weeks prior to randomization; 12. Pregnant or lactating women; or women of childbearing potential with a positive pregnancy test within 7 days prior to the first dose; or women of childbearing potential and their male partners who are unwilling to use effective contraception throughout the study and for 6 months after the last dose; or male subjects who are unwilling to use effective contraception throughout the study and for 6 months after the last dose. 13. History of radiation therapy in the area scheduled for radiation therapy in this study; The investigator deems the subject ineligible for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Incidence of Field Recurrence;Safety;Objective Response Rate;Disease Control Rate;Pattern of Treatment Failure (to evaluate the rationality of small-field radiotherapy field design); | — |
Countries
China
Contacts
Public ContactYe Jinjun
Jiangsu Cancer Hospital
Outcome results
None listed