Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental Group:Colonoscopic fecal microbiota transplantation (FMT) combined with platinum-based chemotherapy and PD-1/PD-L1 inhibitors
Sponsors
General Hospital of Ningxia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years old, gender is not limited; 2. Pathologically or cytologically confirmed non-small cell lung cancer (including adenocarcinoma, squamous cell carcinoma or anaplastic carcinoma) in stage IIIb, IIIc or IV, according to IASLC 8th edition TNM staging criteria; 3. No known driver gene positive mutations such as EGFR, ALK, ROS1, RET (i.e., driver gene negative); 4. PD-L1 expression level =3 months; 7. At least one measurable lesion (according to RECIST 1.1 criteria); 8. Good function of all major organs: 9. Neutrophil >=1.5×10^9/L; 10. Platelets>=100×10^9/L; 11. Hemoglobin >=90 g/L (not dependent on blood transfusion or erythropoietic); 12. ALT/AST=50 mL/min (calculated by the Cockcroft-Gault formula); 15. Able to understand and sign the informed consent form, and voluntarily participate in the study.
Exclusion criteria
Exclusion criteria: 1. Tumor treatment (1) Previous systemic anti-tumor therapy (chemotherapy, targeted therapy or immunotherapy); (2) Active infection (including tuberculosis, hepatitis B (HBV DNA beyond normal), hepatitis C (HCV RNA positive), HIV infection, etc.); (3) Active brain metastases (patients who have been treated and stable = 4 weeks can be enrolled); (4) Previous or current autoimmune diseases requiring systemic treatment (except hormone therapy); (5) Long-term systemic corticosteroid or immunosuppressive therapy is required; (6) Pregnant or lactating women; (7) Those who have recently received live vaccines (within 30 days); 2.2 FMT (1) Patients with severe damage to the intestinal barrier such as sepsis, active bleeding in the digestive tract, perforation, and ulcers due to various reasons, and high risk of enterogenic infection; (2) Current diagnosis of fulminant colitis or toxic megacolon; (3) Enteral nutrition that cannot tolerate 50% heat calorie requirement due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula, etc.; (4) Severely immunosuppressed patients: adult neutrophils <1500/mm^3, lymphocytes < 500/mm^3, childhood granulocytes < 1000/mm^3; (5) Those who have contraindications to graft channel obstruction and transplantation operation itself (endoscopy, catheterization, enema, oral diet). (6) Other researchers consider it unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival,OS;Incidence of Adverse Events,iAE;Quality of Life Questionnaire Score; | — |
Countries
China
Contacts
Public ContactTian Ma
General Hospital of Ningxia Medical University
Outcome results
None listed