Esophagus cancer
Conditions
Interventions
Trial group :After 2 cycles of neoadjuvant chemoimmunotherapy (regimen: adebrelimab 1200 mg d1 + paclitaxel 135 mg/m^2 d1 + carboplatin AUC = 5 d1, every 3 weeks), patients underwent radical esophagec
Sponsors
Jiangsu Cancer Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and provide written informed consent; 2. Age between 18 and 75 years inclusive, either sex; 3. Histopathological diagnosis of esophageal squamous cell carcinoma confirmed by endoscopic biopsy; 4. Eligible for surgical resection of thoracic esophageal cancer; 5. Clinical stage cT1-2N+M0 or cT3-4aNxM0 (AJCC 8th edition); 6. Imaging confirms at least one measurable regional lymph node meeting diagnostic criteria; 7. ECOG performance status of 0–1; 8. Expected survival of at least 3 months; 9. No prior anti-tumor treatment for esophageal cancer, including radiotherapy, chemotherapy, targeted therapy, or surgery; 10. No severe abnormalities in hematopoietic, cardiac, pulmonary, hepatic, renal function, or immunodeficiency; 11. Normal major organ function (no use of blood products, hematopoietic growth factors, leukocyte-boosting agents, platelet-boosting agents, or anemia-correcting drugs within 14 days prior to first dose of study drug): (1) Absolute neutrophil count >= 1.5 × 10^9/L; (2) Hemoglobin >= 9 g/dL; (3) Platelet count >= 100 × 10^9/L; (4) Total bilirubin <= 1.5 × upper limit of normal (ULN); (5) AST (SGOT) and ALT (SGPT) <= 2.5 × ULN; (6) Creatinine <= 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Esophageal perforation or hematemesis; 2. Second primary malignancy (excluding previously cured non-melanoma skin cancer, papillary thyroid carcinoma, stage I seminoma, cervical carcinoma in situ, or other potentially curable tumors, provided that the patient has been disease-free for >= 3 years after treatment); 3. Use of any other investigational drug within 30 days prior to randomization, or concurrent participation in another clinical trial; 4. Any active autoimmune disease, or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.), and use of immunosuppressive agents within the past 28 days; (Note: Patients with hypothyroidism who have received stable hormone replacement therapy for >= 4 weeks and have TSH and FT4 levels within normal range may be included); 5. Known hypersensitivity to macromolecular protein products, or to any component of aderberlib (Adebrelimab) or its formulation; 6. Uncontrolled cardiac symptoms or diseases, including: (1) Heart failure with NYHA functional class >= II; (2) Unstable angina; (3) Myocardial infarction occurring within the past year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 7. Congenital or acquired immunodeficiency (e.g., HIV infection), or active hepatitis B (HBV-DNA >= 10^4 copies/mL), or active hepatitis C (anti-HCV positive and HCV-RNA above the lower limit of detection of the assay), or active tuberculosis; 8. Active infection, or unexplained fever > 38.5°C within 2 weeks prior to randomization (fever due to tumor itself may be included, as determined by the investigator); 9. Sexually active males or females unwilling to use effective contraception during the trial; pregnant or lactating female patients; 10. Other factors, as judged by the investigator, that may lead to premature withdrawal from the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, or family/social factors that may compromise subject safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival,DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Aderberlib Combined with Chemotherapy as Perioperative Treatment for Resectable Esophageal Squamous Cell Carcinoma;R0 Resection Rate;Pathological complete response,pCR;Major pathological response,MPR;Concordance of Pathological Response in Lymph Nodes;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactYe Jinjun
Jiangsu Cancer Hospital
Outcome results
None listed