Esophagus cancer
Conditions
Interventions
Experimental group:Following completion of definitive concurrent chemoradiotherapy (CCRT), patients will receive sintilimab maintenance therapy at a dose of 200 mg administered intravenously every 3 w
Disease progression (PD) as per RECIST criteria
Development of intolerable toxicity
Patient-initiated withdrawal
Investigator-determined discontinuation for safety or protocol compliance reasons.
Control group:After completing definitive concurrent chemoradiotherapy (CCRT), patients will be re-evaluated every 3 months to assess treatment response.
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate and provide written informed consent. 2.Aged 18–80 years, regardless of gender. 3.Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC). 4.Diagnosed with unresectable tumor prior to concurrent chemoradiotherapy (CCRT). 5.Clinical stage II–IVa (UICC 8th edition), including stage IVb with supraclavicular lymph node metastasis but excluding other distant metastatic IVb disease. 6.Intensity-modulated radiation therapy (IMRT) administered at a total dose of 50.4 Gy. 7.Paclitaxel-based chemotherapy during radiotherapy, with at least 2 cycles of a 3-week regimen or 4 cycles of a weekly regimen. 8.Randomization performed 21–28 days after CCRT completion. 9.No disease progression prior to randomization. 10.ECOG performance status 0–1. 11.Expected survival >=3 months. 12.Absence of esophageal perforation, tracheoesophageal fistula, esophagomediastinal fistula, hemorrhage due to arterial invasion, or respiratory stenosis at CCRT completion. 13.No severe dysfunction in hematopoiesis, heart, lungs, liver, kidneys, or immunity.Neutrophils >=1.5×10^9/L; Hemoglobin >=9 g/dL; Platelets >=100×10^9/L; Total bilirubin <=1.5 times the upper limit of normal; AST (SGOT) and ALT (SGPT) <=2.5 times the upper limit of normal; Serum creatinine <=1.5 times the upper limit of normal. 14.Women of childbearing potential must have a negative urine pregnancy test within 14 days prior to randomization. 15.Patients who agree to use adequate contraceptive measures from the time of signing informed consent until 5 months after the last dose of the study drug to prevent pregnancy.
Exclusion criteria
Exclusion criteria: 1.Esophageal perforation or hematemesis. 2.Any active autoimmune disease or history of autoimmune disorders (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, or hypothyroidism [may be included if well-controlled with hormone replacement therapy]), or use of immunosuppressive therapy within 28 days prior to enrollment (except corticosteroids for managing chemoradiation-related toxicities). 3.Failure to recover (> Grade 2) from adverse events (AEs) caused by prior therapy to = Grade 1 or baseline before the first dose of the study drug. AEs deemed unlikely to resolve promptly (e.g., neurotoxicity) by the investigator’s assessment are exclusionary. 4.Presence of non-infectious pneumonitis attributable to prior chemoradiation, as determined by the investigator. 5.Prior or current treatment with anti-PD-1 antibodies or other PD-1/PD-L1-targeted immunotherapy. 6.Known hypersensitivity to macromolecular protein agents or any component of sintilimab or its formulation. 7.Uncontrolled clinically significant cardiac conditions, including: (1) NYHA Class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within the past year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring intervention. 8.Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA >=10^4 copies/mL), active hepatitis C (HCV antibody-positive with HCV-RNA above the lower limit of detection), or active tuberculosis. 9.Active infection or unexplained fever >38.5°C within 2 weeks prior to randomization (fever attributed to tumors by the investigator’s judgment is permitted). 10.Unwillingness to use effective contraception by fertile men or women during the trial; pregnancy, lactation, or planned pregnancy in female patients. 11.Any other condition that, in the investigator’s opinion, may lead to premature study termination, including:Severe concomitant illnesses (including psychiatric disorders) requiring treatment;Familial or social factors compromising patient safety or data integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Objective Response Rate;Safety; | — |
Countries
China
Contacts
Public ContactYe Jinjun
Jiangsu Cancer Hospital
Outcome results
None listed