Clinical Study of Envolizumab Combined With Radiotherapy for Neoadjuvant Treatment of Locally Advanced Thymic Cancer
The aims of this study are to verify the feasibility, effectiveness, and safety of the combination of enrolizumab and radiotherapy for neoadjuvant treatment for locally advanced thymic carcinoma, and to provide recommendations for the establishment of unified evaluation criteria for the neoadjuvant therapy of thymic cancer by evaluating the pathological remission status of thymic cancer specimens after neoadjuvant treatment.
• Pathologically confirmed as thymic carcinoma;
• Clinical staging III-IVA (TNM staging system), non-myasthenia gravis (MG) patients, expected to undergo surgical resection;
• On the day when the subject signs the informed consent form, they are ≥ 18 years old and\<75 years old, regardless of gender;
• The subjects are able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
• Subjects who have not received any anti-thymic tumor treatment in the past, including but not limited to systemic chemotherapy, radiotherapy, or immunotherapy (only those who have received traditional Chinese medicine treatment for anti-tumor indications are allowed to be included, and a cleaning period of at least 2 weeks is required);
• At least 1 measurable lesion (according to the solid tumor efficacy evaluation standard RECIST V1.1);
• Physical fitness score of 0 or 1 (ECOG scoring system of the Eastern Cancer Collaborative Group in the United States);
• Female subjects with fertility must have a negative serum pregnancy test within 7 days before the first administration;
• Female subjects with fertility or male subjects with partners with fertility agree to use efficient contraceptive measures (with an annual failure rate of less than 1%) from 7 days before the first administration until 24 weeks after the end of administration;
⁃ The main organ functions within 7 days before the first administration meet the following standards:
∙ Bone marrow function: hemoglobin ≥ 10.0 g/dL (no blood transfusion received within 28 days before hemoglobin test), absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L (no platelet transfusion or IL-11 treatment received within 14 days prior to platelet count test);
‣ Coagulation function: INR and PT\<1.5 × ULN, APTT ≤ 1.5 × ULN;
‣ Liver function: transaminases (ALT and AST) ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 2.5 in subjects with Gilbert's syndrome or liver metastasis) × ULN);
‣ Renal function: serum creatinine clearance rate ≥ 60 mL/min (calculated according to Cockcroft Fault formula);
‣ Adequate lung function: According to the doctor's judgment, lung function can meet the requirements of thymectomy surgery.