China with high incidence of non-small cell lung cancer. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of lung cancer patients was not significantly decreased. For patients with locally advanced lung cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of lung cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced lung cancer. However, in patients with locally advanced lung cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of serplulimab combined with chemotherapy in the neoadjuvant therapy of resectable non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2, day1; carboplatin AUC=5, i.v, day1. Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1 ; carboplatin AUC=5, i.v, day1.
radical resection of lung cancer
Tumour sample will be collected after surgery
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China, China
Pathological Complete Response (PCR)
No residual invasive tumor cells were found in the pathological examination of resected specimens,including the primary tumor and lymph nodes.
Time frame: 1 month after surgery
Major Pathological Response (MPR)
In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
Time frame: 1 month after surgery
Objective Response Rate (ORR)
The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
Time frame: before surgery
2-year and 5-year overall survival
The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after enrolled
Time frame: 2-year and 5-year after enrolled
Incidence of Treatment-related Adverse Events
Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0
Time frame: 1 month after surgery
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
The changes in the tumor tissue sample among non-PCR (NPCR) and PCR patients
By using mass spectrometry (CyTOF) and single-cell analysis, we comprehensively characterized the immune landscape in the tumor sample of patients after anti-PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response.
Time frame: 3 month after surgery
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