Prospective Phase II Study of Hypofractionated Radiotherapy Sequential Tislelizumab and Anlotinib in the Neoadjuvant and Adjuvant Therapy for Stage II-IIIA Non-Small Cell Lung Cancer
This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.
• (1) Aged 18-75 years old;
• (2) Early stage II-IIIA NSCLC (AJCC 8th edition), NSCLC, confirmed in tissue (AJCC eighth edition);
• (3) All lesions are assessed to be eligible for surgical resection;
• (4) The primary tumor can be treated with hypofractionated radiotherapy after evaluation;
• (5) Epidermal growth factor receptor/anaplastic lymphoma kinase/ROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis;
• (6) ECOG PS score: 0\
⁃ 1;
• (7) Expected survival more than 1 year;
• (8) At least one measurable lesion (RECIST 1.1);
• (9) Females of childbearing potential should agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the study and within 3 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects; and males should agree to use contraceptive measures during the study and within 3 months after the end of the study period;
• (10) Subjects voluntarily participate in this study, sign the informed consent form and had good compliance;
• (11) Subjects are suitable after MDT discussion.