lung cancer
Conditions
Interventions
all patients:Based on CheckMate-816 clinical research, the National Comprehensive Cancer Network (NCCN) guidelines added a neoadjuvant immunochemotherapy regimen: PD-1 inhibitor Opdivo (nivolumab) com
Sponsors
The First Affiliated Hospital, Zhejiang University of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Fifty patients, who are diagnozed with non-small cell lung cancer in department of thoracic surgery, the First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, as well as will receive radical surgery and neoadjuvant immunotherapy combined with chemotherapy, will be recruited in this study. The study period is from Jun 1, 2023 to December 31, 2023. The inclusion criteria are listed as follows: 1.Patients with NSCLC are willing to participated in this study and to sign the informed consent form. 2.Patients’s age is =18 years, or =80 years. 3.Patients undergo complete excision of the primary NSCLC lesion. 4.The Eastern Cooperative Oncology Group (ECOG) body status score of patients is 0 or 1. 5.NSCLC patients are at stage II-IIIB (N2), based on Tumor Node Metastasis (TNM) staging system (8th edition) . 6.There are measurable lesions according to the solid tumor efficacy evaluation criteria version 1.1 (RECIST 1.1). 7.All suspected mediastinal lymph nodes (including pathological enlargement or fluorodeoxyglucose (FDG) concentration on Positron Emission Tomography / Computed tomography (PET / CT)), if available by endobroncheal ultrasonography(EBUS)and thoracoscopy, require further sampling for pathological confirmation. 8.The NSCLC patient never received any form of treatments after the diagnosis.
Exclusion criteria
Exclusion criteria: The exclusion criteria are listed as follows: 1.Patients age is 80 years. 2.Patients had small cell lung cancer or small cell lung cancer mixed with non-small cell lung cancer. 3.The patient received any form of treatments after diagnosis. 4.The NSCLC patients had untreated brain metastases or other distant metastases (M1). 5.The NSCLC patients at stage N0 or N3, bassed on the TNM staging system (8th edition). 6.Patients did not undergo radical surgery and systematical lymphadenectomy. 7.The NSCLC patients were treated with other immunosuppressants or glucocorticoids. 8.The NSCLC patients were treated with antibiotics for infectious diseases within 1 month before and during treatment with neoadjuvant immunocombined chemotherapy. 9.Patients had history of allogeneic organ or bone marrow transplantation. 10.Patient had history of active primary immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| characterization of oral microbiome; | — |
Secondary
| Measure | Time frame |
|---|---|
| characterization of intratumoral microbiome; | — |
Countries
China
Contacts
Public ContactFu Baiping and Hu Jian
the First Affiliated Hospital, Zhejiang University School of Medicine/ Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Clinical Research Center for Oral Diseases of Zhejiang Province, Key Laboratory of Oral Biomedical
Outcome results
None listed