Lung Cancer
Conditions
Interventions
case series:Nil
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) According to the 8th edition of the TNM staging of lung cancer by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification,diagnosed as advanced (Stage IV) non-small cell lung cancer by cytology or histology,with inoperable treatment and unable to receive radical concurrent radiotherapy and chemotherapy . 2) Aged 18 Years to 70 Years patients voluntarily participate in this study. 3) Have not received systemic treatment for NSCLC in the past.For patients who have previously received adjuvant chemotherapy, neoadjuvant chemotherapy for the purpose of curing non-metastatic disease, or have received radical radiotherapy and chemotherapy for advanced disease, if the disease progression occurs more than 6 months after the end of the last treatment can participate in this study. 4) The expected survival period is >= 3 months. 5) PD-1 monoclonal antibody immunotherapy or PD-1 monoclonal antibody combined with chemotherapy and radiotherapy are planned clinically. 6) Without planned abdominal radiotherapy.
Exclusion criteria
Exclusion criteria: 1) Women during pregnancy or breastfeeding. 2) Have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody treatment, or any other antibody or drug treatment for T cell costimulation or checkpoint pathway, such as ICOS or agonists (such as CD40,CD137,GITR,OX40, etc.). 3) Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or in the follow-up period of an interventional study (defined as the time between the first use of PD-1 monoclonal antibody and the last clinical study is more than 28 days or more than 5 half-lives of the study drug). 4) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 5) Suffer from active, known or suspected autoimmune diseases, or have a history of autoimmune diseases. Except for: Vitiligo, alopecia, Graves disease, psoriasis or eczema that does not require systemic treatment within the past 2 years, and hypothyroidism that requires only a stable dose of hormone replacement therapy (caused by autoimmune thyroiditis) And type I diabetes that only requires a stable dose of insulin replacement therapy, or subjects whose childhood asthma has been completely relieved, and no intervention is required after adulthood, or the disease will not recur without external triggers. 6) Participants who required systemic corticosteroid (equivalent to >10 mg prednisone/day) or other immunomodulator (interleukin-2, IFN-, IFN-, cyclosporine, g-csf, mTOR inhibitor) treatment within 14 days prior to enrollment. 7) A known history of primary immunodeficiency virus infection.8)Receive abdominal radiotherapy and take radioactive substances within 28 days prior to enrollment.9)Active or previously recorded inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, chronic diarrhea). Patients with chronic diarrhea who had no recurrence within 2 years before enrollment were excluded. 10) A history of gastrointestinal perforation and/or fistula within 6 months before the first use of PD-1 monoclonal antibody. 11) Suffered from other active malignant tumors within 5 years before enrollment. Except for locally curable cancers (shown as cured), such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ. 12) Major surgery (defined by the investigator, such as open biopsy, severe trauma, etc.) within 28 days before the first use of PD-1 monoclonal antibody. 13) Known history of active tuberculosis (TB). Subjects suspected of having active TB need to be checked for chest X-ray, sputum, and to be excluded through clinical symptoms and signs. 14) Infections occurred within 28 days before the first use of PD-1 monoclonal antibody, including but not limited to complications that require hospitalization, sepsis or severe pneumonia. 15) There is an active infection that requires systemic treatment. 16) Untreated patients with chronic hepatitis B, HBV carriers with chronic hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or patients with active hepatitis C should be excluded. Inactive HBsAg carriers, treated and stable hepatitis B patients (HBV DNA <500 IU/mL), and cured hepatitis C patients can be included in the group. 17) Those who have received a live vaccine or attenuated vaccine within 30 days before the first use of PD-1 monoclonal antibody, or plan to receive the vaccine during the study period. 18) Any condition that the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS;PFS; | — |
Countries
China
Contacts
Public ContactMeijuan Huang
West China Hospital, Sichuan University
Outcome results
None listed