Esophageal cancer
Conditions
Interventions
Group 1:Adbelimab combined with chemotherapy for adjuvant treatment after surgery
Group 2:Adbelimab adjuvant therapy after surgery
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, regardless of gender; 2. Patients with resectable esophageal squamous cell carcinoma confirmed by histopathology or cytology (patients who received neoadjuvant therapy previously and were confirmed as pN+ or pT+ by postoperative pathological examination; or patients who had no prior neoadjuvant therapy and were confirmed as pN+ or pT3-4 by postoperative pathological examination); 3. ECOG performance status: 0–1; 4. No evidence of tumor progression or recurrence confirmed by imaging within 4 weeks prior to signing the informed consent form or receiving the first treatment after radical surgery; 5. The interval from radical surgery to the first administration is not less than 1 month and not more than 3 months; 6. The investigator judges that the patient has recovered from radical surgery and is able to tolerate treatment with the study drug; 7. Adequate organ and bone marrow function, defined as follows: Hemoglobin >= 9.0 g/dL, Absolute Neutrophil Count (ANC) >= 1.5×10?/L, Platelet count >= 100×10?/L, INR = 3.0 g/dL, Serum creatinine 60 mL/min, or calculated creatinine clearance > 60 mL/min according to the Cockcroft-Gault formula (applying actual body weight): For males: Creatinine clearance = (Body weight × (140 - Age)) / (72 × Serum creatinine) For females: Creatinine clearance = (Body weight × (140 - Age)) / (72 × Serum creatinine) × 0.85 Where: CL = mL/min; Serum creatinine = mg/dL; 8. Expected survival >= 12 weeks; 9. The patient has signed the informed consent form and voluntarily participates in this study.
Exclusion criteria
Exclusion criteria: 1. At high risk of esophageal fistula, e.g., a history or relevant symptoms of esophageal fistula, or primary tumor invasion into major blood vessels or the trachea; 2. Evidence of complete esophageal obstruction, making the patient unsuitable for treatment; 3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease [e.g., colitis or Crohn’s disease], diverticulitis [excluding diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, Wegener’s syndrome [granulomatosis with polyangiitis], Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). Exceptions to this criterion are as follows: (a) Patients with vitiligo or alopecia; (b) Patients with hypothyroidism (e.g., post Hashimoto’s syndrome) receiving stable hormone replacement therapy; (c) Any chronic skin disease not requiring systemic therapy; (d) Patients with no active disease for the past 5 years may be enrolled, but only after consultation with the study investigator; (e) Patients with celiac disease controlled solely by diet; 4. Active infections, including tuberculosis (clinical evaluation shall include clinical history, physical examination, imaging results and tuberculosis tests in line with local treatment principles); 5. Uncontrolled comorbidities, including but not limited to persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmias, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or psychiatric disorders/social conditions that impair adherence to study requirements, significantly increase the risk of adverse events (AEs), or compromise the patient’s ability to provide written informed consent; 6. A prior history of thyroid dysfunction, with thyroid function failing to remain within the normal range despite pharmacotherapy; 7. Current or prior use of immunosuppressive drugs within 14 days prior to the first administration of adebrelimab. Exceptions to this criterion are as follows: (a) Intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injections); (b) Systemic glucocorticoids at a dose not exceeding the physiological level, equivalent to 10 mg/day of prednisone or its equivalent; (c) Corticosteroids used as premedication for hypersensitivity reactions (e.g., premedication for CT scans); 8. A history of psychoactive substance abuse with inability to abstain, or presence of psychiatric disorders; 9. A known history or evidence of interstitial lung disease or active non-infectious pneumonia; 10. Administration of live attenuated vaccines within 30 days prior to the first dose of the study drug. Note: If enrolled, patients must not receive live vaccines during the study drug treatment period and within 30 days after the last administration of the study drug; 11. A known history of allergic or hypersensitivity reactions to any study drug or any of its excipients; 12. Concurrent enrollment in another clinical study, unless the study is an observational (non-interventional) clinical study or the follow-up phase of an interventional study; 13. Other conditions deemed unsuitable for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival;3-years overall survival rate; | — |
Countries
China
Contacts
Public ContactZhang Renquan
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed