Explorative study, which evaluates the effect of Tislelizumab combined with chemotherapy in neoadjuvant treatment of stage Ⅲ unresectable non-small-cell lung carcinoma.
This is a open-label, single-arm prospective clinical trial to evaluate the efficacy and safety of Tislelizumab combined with chemotherapy in neoadjuvant treatment of newly diagnosed stage Ⅲ unresectable non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, neoadjuvant therapy : 2-4 cycles; Adjuvant therapy: 16cycles at most.
Pemetrexed: 500 mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles. Nab-paclitaxel: 260mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles.
Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 ivgtt on day 1 of each 21-day cycle for 2-4 cycles. Cisplatin: 75 mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles.
the Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGR0 Resection Rate
R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.
Time frame: 1 month after surgery
Objective Response Rate (ORR)
Objective Response Rate (ORR): defined as the proportion of patients whose tumor size shrinks to predefined values,which including cases of CR and PR. Objective tumor response will be assessed using RECIST 1.1. Subjects must have measurable tumor lesions at baseline, and the response evaluation criteria are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1.
Time frame: Pre-operation
Resectability Rate
Resectability Rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Time frame: Pre-operation
Major Pathological Response (MPR) Rate
Major Pathological Response (MPR) Rate: defined as ≤ 10% of residual tumor cells in the surgically resected tumor specimen and sampled regional lymph nodes after neoadjuvant treatment.
Time frame: 1 month after surgery
Rate of grade 3 and higher grade treatment-related adverse events
Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Time frame: From date of treatment allocation until surgery or within 30 days after last dose of preoperative treatment
Progression-Free Survival (PFS)
Progression-Free Survival (PFS): defined as the time from the first dose until the date of first documented progression or date of death from any cause, whichever came first.
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Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment.
Time frame: Up to 12 months