lung cancer
Conditions
Interventions
Control group:placebo
Experimental group:lactic acid beneficial metabolites
Sponsors
People's Hospital of Inner Mongolia Autonomous Region
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged >=18 years at the start of the study, regardless of gender; 2. Histologically or cytologically confirmed NSCLC, and participants with stage III inoperable or IV tumors (as judged by the International Association for the Study of Lung Cancer (IASLC) Thoracic Tumor Staging Manual, 8th Edition); 3. Gene detection EGFR(-), ALK(-) subjects; 4. Subjects must have measurable lesions according to RECIST 1.1 criteria; 5. The ECOG score is at least 0 or 1; 6. Systemic subjects who have received any number of operations, interventional therapy, chemotherapy, radiotherapy, etc. must meet all the following entry criteria to be eligible to enter this study; 7. The subject has not received systemic chemotherapy and immunotherapy for advanced/metastatic NSCLC before; 8. The expected survival period is greater than 6 months; 9. The functions of vital organs meet the following requirements (any blood components, cell growth factors, whitening drugs, platelet increasing drugs, and anemia correction drugs are not allowed to be used within 14 days before the first use of the research drug): (1) Absolute neutrophil count (ANC) >= 1.5x10^9/L; (2) Platelets >= 100x10^9/L; (3) Hemoglobin>= 9g/dL; (4) Serum albumin >= 2.8g/dL; (5) Total bilirubin <= 1.5xULN, ALT, AST and/or AKP <= 2.5xULN; (6) Serum creatinine <= 1.5xULN or creatinine clearance rate greater than 60mL/min; 10. Agree and have the ability to take probiotic Bifidobacterium lactis V9 (Kex02) solid drink; 11. Subjects need to sign informed consent; 12. Subjects agree to undergo follow-up medical imaging examinations to determine the progression of lesions, agree to provide stool samples before and after taking probiotic Bifidobacterium lactis V9 (Kex02) and at each return visit; 13. Female subjects of childbearing age must have a negative pregnancy test within 7 days before starting treatment, and be willing to take strict contraceptive measures until 120 days after the last immune checkpoint inhibitor.
Exclusion criteria
Exclusion criteria: 1. Breastfeeding, and men who are not taking effective contraceptive measures who are sexually active with WOCBP; 2. Subjects with active central nervous system (CNS) metastasis; 3. The subject has previously or concurrently suffered from other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4. Subjects who have been treated with immune checkpoint inhibitors in the past cannot be enrolled; the subject is known to be allergic to macromolecular protein preparations, or to any immune checkpoint inhibitor, or to the chemotherapy components used during treatment; 5. The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid function is reduced, and those who have received thyroid surgery in the past cannot be included; subjects with vitiligo or complete remission of asthma in childhood can be included without any intervention in adulthood; subjects with asthma requiring bronchodilator medical intervention are not included); 6. The subjects are using immunosuppressive, or systemic, or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose >10mg/day prednisone or other equivalent therapeutic hormones), and continue to use it within 2 weeks before enrollment; 7. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 8. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) NYHA grade 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) subjects with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9. Abnormal coagulation function (PT > 16s, APTT > 43s, TT > 21s, Fbg > 2g/L), with bleeding tendency or receiving thrombolytic or anticoagulation therapy; 10. Previous or current severe bleeding (bleeding > 30 ml within 3 months), hemoptysis (fresh blood > 5 ml within 4 weeks) or a thromboembolic event (including stroke and/or transient ischemic attack) within 12 months; 11. Subjects with active infection or unexplained fever > 38.5 degrees during the screening period and before the first administration (subject to the investigator's judgment, the subjects with fever due to tumor can be enrolled); 12. Subjects with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 13. Subjects with congenital or acquired immunodeficiency, such as HIV-infected persons, or active hepatitis (Transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA >= 10^3/ml; hepatitis C reference: HCV RNA >= 10^3/ml); chronic hepatitis B virus carriers, HBV DNA < 2000 IU/ml (< 10^4 copies/ml), must receive antiviral therapy at the same time during the trial before they can be enrolled; 14. The subject is participating in other clinical studies or less than 1 month after the end of the previous clinical study; the subject may receive other systemic anti-tumor therapy during the study; 15. Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study period; 16. The subject is known to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observation of clinical efficacy indicators;Intestinal mucosal barrier;Inflammatory factors;Changes in the intestinal flora;Intestinal flora metabolomics; | — |
Countries
China
Contacts
Public ContactDong Li
People's Hospital of Inner Mongolia Autonomous Region
Outcome results
None listed