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.
This study is a single-center, prospective, single-arm, exploratory clinical study aimed at evaluating 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. If the subject does not voluntarily withdraw from the trial, or the toxic and side effects caused by the drug are intolerable, or the investigator considers that the subjects are not suitable for further trials, each subject will receive the following treatments before and after surgery, and the efficacy evaluation and follow-up will be performed in each cycle. After completing all screening activities, eligible patients will enter the study and receive the following treatment and visits: First, receive 24 Gy (8 Gy\*3) of hypofractionated treatment on d1-3 after the start of the study, and then receive neoadjuvant therapy with tislelizumab combined with anlotinib within 1 week after radiotherapy. Each 3 weeks is a medication cycle, for a total of 2 cycles. Patients will undergo radical surgery after neoadjuvant treatment, and then receive tislelizumab and anlotinib adjuvant treatment after surgery. Each 3 weeks is a medication cycle, and it is maintained for 1 year. The 1-year event-free survival (EFS) rate, complete pathological response (pCR) and major pathological response (MPR) were evaluated to evaluate the safety of medical/surgical treatment for patients. Neoadjuvant therapy regimen (2 cycles): 1. Receive 3-day hypofractionated treatment on Day 1, Day 2, and Day 3, with a total dose of 24Gy (8Gy\*3). 2. Within 1 week after radiotherapy, receive neoadjuvant tislelizumab (200 mg, intravenous drip, d1) combined with anlotinib (10 mg, oral, D1-14) . Each 3 weeks is a medication cycle. Surgical protocol: The surgical approach was determined by the surgeon according to the patient's condition, including but not limited to thoracoscopic/open lobectomy/sleeve lobectomy/combined lobectomy/pneumonectomy. Lymph node dissection requires at least three stations of mediastinal lymph node dissection. Adjuvant therapy regimen: tislelizumab (200 mg, intravenous drip, d1) combined with Anlotinib (10 mg, oral, D1-14). Each 3 weeks is a medication cycle, for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation by blocking VEGFR, FGFR, PDGFR, and c-Kit simultaneously.
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody.
Hypofractionated Radiotherapy Extent of radiotherapy: Primary lesion in the lung. Radiotherapy technique: IGRT. Radiotherapy delivery equipment: linear accelerator or TOMO accelerator or CyberKnife.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGpCR Rate
Complete pathological response (pCR), defined as the proportion of patients in the ITT analysis set and surgical population analysis set who have no residual tumor in the resected primary tumor and metastatic lymph nodes as assessed by the investigator after the completion of neoadjuvant therapy. Patients who do not meet these criteria, including those who do not undergo surgical resection, will be considered non-responders.
Time frame: 12 months
1-year EFS Rate
1-year EFS rate is defined as the proportion of patients who have not experienced radiographic disease progression, local recurrence or distant metastasis, or death due to any cause assessed by the investigator according to RECIST 1.1 Version, from enrollment to 1 year in the intent-to-treat (ITT) analysis set. The 1-year EFS rate is evaluated by the Kaplan-Meier (KM) method.
Time frame: Baseline up to 1 years
MPR Rate
Major pathological response (MPR) was defined as the proportion of patients in the ITT analysis set and surgical population analysis set with ≤ 10% residual viable tumor cells in the resected primary tumor and metastatic lymph nodes after the completion of neoadjuvant therapy as assessed by the investigator. Patients who do not undergo surgical resection for reasons such as disease progression will be considered non-responders.
Time frame: 12 months
Adverse Events (AEs) according to CTCAE (V5.0) (Safety Evaluation)
The number of abnormal data on potential adverse reaction
Time frame: Baseline up to 3 years
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