lung cancer
Conditions
Interventions
Treatment group :ICIs ± chemotherapy+ Yang Yin Wen Yang formula
Control group:ICIs ± chemotherapy
Observation Group:none
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Observational Study: (1) Patients diagnosed with advanced NSCLC (non-small cell lung cancer) through cytology or histopathology. (2) Age =18 and =85, gender not specified. (3) Patients who are preparing for or currently receiving ICIs (immune checkpoint inhibitors) ± chemotherapy. (4) Patients capable of reading, understanding, and completing the relevant questionnaires. (5) Patients who understand, agree to participate in this study, and sign the informed consent form Interventional Study: (1) Patients diagnosed with advanced NSCLC confirmed by pathological examination; (2) Age = 18 years and = 85 years, regardless of gender; (3) Patients planning to receive ICIs±chemotherapy; (4) Performance status score (ECOG PS) = 2; (5) Normal function of major organs, absolute neutrophil count > 1.5 × 109 /L, platelet count > 80 × 109 /L, hemoglobin > 90 mg/dL; normal liver and kidney function; (6) Willingness to participate in this study, understanding the study requirements, and signing the informed consent form.
Exclusion criteria
Exclusion criteria: Observational Study: (1) Patients currently undergoing targeted therapy, radiation therapy, or monotherapy. (2) Patients with uncontrolled systemic diseases such as heart, brain, liver, kidney, etc. Interventional Study: (1) Patients currently diagnosed with malignant diseases or having a history of malignant diseases (except for resected NSCLC), with severe diseases affecting the heart, liver, kidney, and hematopoietic system diagnosed and/or requiring treatment within the past three years; (2) Patients unable to tolerate standard ICIs±chemotherapy; (3) Patients with a history of uncontrolled mental illness; (4) Patients who are pregnant or breastfeeding; (5) Patients known to be allergic to the herbal ingredients used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Symptoms(Interventional Study);Severity of Symptoms(Observational Study);Clinical efficacy(Observational Study); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate(Interventional Study);Lung Immune Prognostic Index(Interventional Study);Intestinal microbiota(Interventional Study); | — |
Countries
China
Contacts
Public ContactGu Yifeng
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed