To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer.
This study is a prospective, single-arm, single-center phase II clinical trial to investigate the efficacy and safety of neoadjuvant treatment with tirilizumab in combination with chemotherapy in patients with initially inoperable stage III/N2 non-small cell lung cancer. Patients with stage III/N2 non-small cell lung cancer that is initially inoperable and clearly staged and meets the enrollment criteria will receive 3 cycles of tirilizumab (200 mg) in combination with chemotherapy and will be evaluated by imaging of their tumor status. After MDT evaluation patients will either undergo surgery or be withdrawn from the study and receive a combination of radiotherapy and chemotherapy, with postoperative adjuvant therapy at the discretion of the physician. The primary endpoint of this study is the surgical conversion rate; secondary endpoints include MPR, pCR, safety, and EFS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Tislelizumab 200mg Q3W,Platinum-containing dual drug chemotherapy
Surgical conversion rate
After 3 cycles of Tislelizumab combined with chemotherapy, the number of patients who underwent surgical resection/number of patients enrolled
Time frame: Within 4-6 weeks (+7 days) after the third cycle of Tislelizumab combined with chemotherapy
Major pathologic response(MPR)
Less than 10% of tumor cells remained in the pathological excision specimen
Time frame: Within one week after surgery
Pathologic Complete response(pCR)
No tumor cells were observed in pathological excision specimens
Time frame: Within one week after surgery
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