lung cancer
Conditions
Interventions
Experimental group:PD-1 monoclonal antibody + Qidongning Formula
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years and = 75 years old gender not limited; 2) Histopathological diagnosis of NSCLC according to AJCC Lung Cancer TNM Staging (9th Edition) stage IIIA - IV; 3) First application of anti-tumor regimens containing PD-1 inhibitors (within third-line treatment); 4) TCM diagnosis of qi-yin deficiency syndrome; 5) ECOG score: = 2 points expected survival period = 3 months; 6) Understand and agree to participate in this study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with other primary malignant tumors currently under treatment; 2) Patients who have contraindications to immunotherapy based on the pre-immunotherapy baseline assessment (such as having severe immune system diseases); 3) Patients with severe primary diseases of the heart brain blood vessels liver kidney hematopoietic system etc.; 4) Pregnant and lactating patients; 5) Patients with a history of oral allergy contraindications or intolerance to the main components of Qidongning Formula; 6) Patients with accompanying diseases that according to the investigator's judgment seriously endanger the safety of the research participants or affect the completion of the study or are considered to have other reasons that make them unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in CD4+ T lymphocytes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Changes in cytokine counts;Changes in CD8+ T lymphocytes count;Progress Free Survival;Duration of drug treatment;Overall survival;Changes in CD4+/CD8+;Changes in CD3+ T lymphocytes count;Eastern Cooperative Oncology Group score;Changes in B-cell count;Disease control rate;The incidence rate of adverse reactions related to immunotherapy;Quality of life score;Peripheral blood mononuclear cell single-cell sequencing;Scoring of Clinical Syndromes in Traditional Chinese Medicine;Changes in natural killer cells (NK) count; | — |
Countries
China
Contacts
Public ContactSu Lingzi
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed