Esophageal cancer
Conditions
Interventions
Test group:Postoperative adjuvant therapy with camrelizumab combined with albumin-bound paclitaxel and cisplatin
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–75 years, male or female. 2. Patients with pathologically (histologically or cytologically) confirmed resectable esophageal squamous cell carcinoma. 3. No prior anti-tumor therapy before surgery. 4. Underwent radical resection with R0 resection status. [For surgical treatment in this study, the procedure requires esophagogastric partial resection with esophagogastric cervical anastomosis via a right thoracotomy, cervical, and abdominal three-incision approach, combined with two-field and/or three-field lymphadenectomy. A gastric tube is used to replace the resected esophagus, and the anastomosis is performed via the posterior mediastinal or retrosternal route. Lymphadenectomy is performed in accordance with the classification of the Japan Esophageal Society (JES).] 5. Postoperative pathological confirmation of pN+ or pT3–4 disease. 6. ECOG performance status score of 0 or 1. 7. Expected survival >= 6 months. 8. Adequate organ function, no severe dysfunction or immunodeficiency involving hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow systems. Laboratory values must meet the following criteria: (1) Hemoglobin (Hb) >= 90 g/L; (2) White blood cell (WBC) count >= 3.0×10?/L; absolute neutrophil count (NEUT) >= 1.5×10?/L; (3) Platelet (PLT) count >= 100×10?/L; (4) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <= 2.5 × upper limit of normal (ULN); serum creatinine (sCr) <= 1.5 × ULN; (5) Total bilirubin (TBIL) <= 1.5 × ULN; (6) Urine protein and urine occult blood < 2+; fecal occult blood < 2+. 9. Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and cooperate with follow-up. 10. In the investigator’s judgment, the patient is likely to benefit from treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed hypersensitivity to the study drug and/or its excipients. 2. Cervical esophageal cancer and/or history of other malignant tumors. 3. Received preoperative antineoplastic therapy including chemotherapy, targeted therapy, immunotherapy, etc. 4. Subjects who received additional chemotherapy, radiotherapy, targeted therapy or immunotherapy after surgery. 5. Suffering from any active autoimmune disease or history of autoimmune disease. Subjects with childhood asthma in complete remission without any intervention in adulthood, or with vitiligo may be enrolled; subjects requiring medical intervention with bronchodilators are not eligible. 6. Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/mL), hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay), or co-infection with hepatitis B and C; or history of organ transplantation. 7. Presence of poorly controlled cardiac symptoms or diseases, such as: (1) Heart failure of NYHA class >= II; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year. 8. Postoperative pathological lymph node status cannot be assessed (pNx). 9. Received medications that may affect the efficacy of immunotherapy within 2 weeks prior to the first dose, such as corticosteroids, antibiotics, proton pump inhibitors. 10. Pregnant or lactating women. 11. Patients judged by the investigator to be ineligible for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;3 year overall survival rate; | — |
Countries
China
Contacts
Public ContactNingning Kang
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed