To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for early resectable NSCLC patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day)
Xiangya Hospital of Central South University
Changsha, Hunan, China
Pathological complete response
The percentage of participants with 0% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy, as assessed by a blinded independent pathological review.
Time frame: Within 3 days after the operation
Objective response rate
The percentage of participants who achieved complete response or partial response after 3 cycles of neoadjuvant therapy according to the RECIST 1.1 criteria.
Time frame: 28 days after the completion of three cycles of neoadjuvant therapy and before the operation
Major Pathologic Response
The percentage of participants with no more than 10% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy, as assessed by a blinded independent pathological review.
Time frame: Within 3 days after the operation
Disease free survival
The time (month) from the completion of lung cancer radical surgery to the recurrence or metastasis of the disease.
Time frame: 1 year, 3 years and 5 years after the operation
Recurrence rate
The percentage of participants who have recurrence or metastasis of lung cancer at certain time points after radical surgery.
Time frame: 1 year, 3 years and 5 years after the operation
Overall survival
The time (month) from the completion of lung cancer radical surgery to all-cause death.
Time frame: 1 year, 3 years and 5 years after the operation
Adverse effects
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The number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Treatment-related adverse events were assessed between the first neoadjuvant dose and 30 days after the last dose of neoadjuvant study treatment.
Surgical complications (intra-operative and peri-operative)
The number of participants with surgery-related adverse events that occur during or after a surgical procedure.
Time frame: 90 days after the first medication or 30 days after the operation, whichever is later
R0 surgical events
The number of participants who have lung cancer completely resected. It is defined as the removal of negative margins, encompassing bronchial, arterial, venous peribronchial, and surrounding tissues near the tumor. In addition, at least 6 groups of lymph nodes must be removed, including at least 3 groups of intrapulmonary lymph nodes and 3 groups of mediastinal lymph nodes (station 7 lymph node must be included). The resected lymph nodes should be negative upon microscopic examination.
Time frame: 28 days after the completion of three cycles of neoadjuvant therapy
Clinical TNM downstaging
The number of participants who achieve a decrease in the clinical TNM stage of lung cancer following neoadjuvant therapy before surgery.
Time frame: 28 days after the completion of three cycles of neoadjuvant therapy and before the operation