Lung Cancer
Conditions
Interventions
Control group:Chinese herbal placebo + Immune Checkpoint Inhibitors ± Chemotherapy
Treatment Group:Lumaiyifei Formula + Immune Checkpoint Inhibitors ± Chemotherapy
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with advanced non-small cell lung cancer (including stage IV and unresectable stage III) based on pathological and imaging findings; 2. Age =18 years and =75 years with no gender restrictions; 3. Patients planned to receive ICIs treatment; 4. Performance status score (ECOG PS) =2; 5. Normal major organ function: absolute neutrophil count >1.5×10?/L platelet count >80×10?/L hemoglobin >90 mg/dL; normal liver and kidney function; 6. Able to understand agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of any active lung disease (including interstitial pneumonia radiation pneumonitis clinically symptomatic active pneumonia or severe pulmonary dysfunction) autoimmune disease or a history of autoimmune disease (including but not limited to autoimmune hepatitis interstitial pneumonia etc.); 2. Any medical condition with an expected survival of less than 2 months; 3. History of uncontrolled psychiatric disorders; 4. Pregnant or lactating patients; 5. Known allergy to the traditional Chinese medicine components used in this study; 6. Long-term use of immunosuppressive drugs; 7. Symptomatic brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life;Overall survival;Progress free survival;MD Anderson Traditional Chinese Medicine (TCM) Clinical Symptoms;Lung immune prognostic index;Peripheral blood immune function; | — |
Countries
China
Contacts
Public ContactYichao Wang
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed