lung cancer
Conditions
Interventions
Experimental group:PD-1/PD-L1 inhibitors + chemotherapy + WD-3 mixture granules
Control group:PD-1/PD-L1 inhibitors + chemotherapy + WD-3 mixture granule mimic
Sponsors
Wuxi Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria of Western medicine and are diagnosed as lung adenocarcinoma or squamous cell carcinoma with TNM stage IIIb-IV; EGFR/ALK/ROS-1/c-MET driver gene mutation was not detected, and PDL1 immunohistochemical test results were clear; 2. TCM syndrome differentiation diagnosis is lung qi deficiency syndrome type: long cough thin sputum, chest stuffy short breath, fatigue, abdominal distension and lethargy, bloated loose stool, tongue light moss thin, tooth marks on the edge, and thin pulse; 3. Measurable target lesions; 4. Physical strength score (Eastern Cooperative Oncology Group (ECOG)) =18 years old; 6.Volunteer to participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients who have received any tumor specific radiotherapy, chemotherapy, targeted or immunotherapy within one month; 2.Gene detection of pathological tissue, blood and body fluid samples showed positive mutations of EGFR, ALK, ROS-1 and other genes, which was suitable for patients taking corresponding targeted drugs. 3. Patients with symptomatic brain metastases; 4. Patients with severe bleeding tendency, platelet less than 50×10^9/L and severe coagulation disorder; 5. Pregnant and lactating women; Or liver, kidney, heart, lung, brain serious insufficiency; Or severe anemia, dehydration and severe disorder of nutrient metabolism, which cannot be corrected or improved in a short time; Or severe systemic infection, high fever (T>38.5?); 6.HIV antibody positive, or suffering from other acquired, congenital immunodeficiency disease patients; 7. Patients with a history of organ transplantation; 8. Patients enrolled in other clinical trials within three months. 9. Patients who are receiving other Chinese medicines with antitumor effects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Quality of life score; | — |
Countries
China
Contacts
Public ContactChunhui Jin
Wuxi Hospital of Traditional Chinese Medicine
Outcome results
None listed