Lung cancer
Conditions
Interventions
Intervention group:Vitamin K2 combined with immuno-chemotherapy for non-small cell lung cancer
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subject or their legal guardian and/or impartial witness voluntarily signs the informed consent form; 2. At the time of signing the informed consent form, the subject's age is between 18 and 80 years old (inclusive), regardless of gender; 3. Non-small cell lung cancer (NSCLC) confirmed by histological or cytological examination, with radiographic evidence (computed tomography [CT], magnetic resonance imaging [MRI], or pathological evidence); 4. Eastern Cooperative Oncology Group (ECOG) performance status = 30 mL/min; 6. The subject has not previously undergone anti-tumor immunotherapy or chemotherapy; 7. The investigator determines that the subject's expected survival time is at least 12 weeks; 8. At screening, women of childbearing potential (e.g., women who have not undergone surgical sterilization or have not been postmenopausal for at least one year) must have a negative serum pregnancy test result. Both male and female subjects of childbearing potential agree to use effective contraceptive measures throughout the study and for at least 6 months after the study ends.
Exclusion criteria
Exclusion criteria: 1. Severe systemic infections, nasopharyngeal or oral inflammations (e.g., periodontitis, gingivitis, tonsillitis), respiratory infections, soft tissue or skin infections, abscesses, or endocarditis within the past 3 months; 2. Use of the following medications for more than one week within the past 3 months: antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, probiotics, hormones, immunosuppressants, or anti-tumor chemotherapy drugs; 3. A history of severe constipation or diarrhea, or significant changes in bowel habits within the past 3 months; 4. A personal history of tumors (e.g., oral cancer, throat cancer, esophageal cancer), organ transplantation, or severe parasitic infections, as well as other digestive system diseases (e.g., inflammatory bowel disease, liver cirrhosis); 5. A history of trauma or surgery within the past 3 months; 6. Digestive issues such as peptic bleeding, obstruction, or perforation within the past 3 months; 7. Poorly controlled chronic metabolic, infectious, or endocrine diseases (e.g., hypertension, diabetes, hyperlipidemia, hyperuricemia, hyperpurinemia, thyroid dysfunction); 8. Vegetarianism or significant dietary habit changes within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of irAEs from the beginning of treatment to the 73rd week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of irAEs occurring in subjects from baseline to every 3-week interval;Efficacy was evaluated from baseline to every 6 weeks; | — |
Countries
China
Contacts
Public ContactXiaoyan Shao
Xuzhou Central Hospital
Outcome results
None listed