COPD and NSCLC
Conditions
Interventions
Xiaoqinglong Decoction combined with immunotherapy group:Xiaoqinglong Decoction combined with immunotherapy
Standard immunotherapy group:immunotherapy
Sponsors
Subei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1: age =18 years old; 2: patients with histologically or cytologically confirmed unresectable stage III to IV NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM lung Cancer staging); 3: Subject had at least one measurable lesion according to RECIST v1.1; 4: patients with a forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) less than 70% after bronchodilator inhalation, and a predicted FEV1% value of pulmonary function test less than 80%, and COPD patients in stable condition for more than 2 weeks; 5: subjects had not received Xiaoqinglong decoction and immunotherapy before; 6: no previous anti-tumor treatment, expected survival time >3 months; 7: The organ function of the subjects should meet the requirements of laboratory indicators; 8: For female subjects of reproductive age, a negative urine or serum pregnancy test should be obtained within 3 days prior to receiving the first dose of study drug (day 1 of cycle 1). If a urine pregnancy test result could not be confirmed as negative, a blood pregnancy test was requested. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy. 9: If there was a risk of pregnancy, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug on treatment (or 180 days after the last dose of chemotherapy drug)
Exclusion criteria
Exclusion criteria: 1: the subjects had a history or concurrent history of other malignant tumors; 2: subjects with a history of asthma or other respiratory diseases (pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss syndrome, active pulmonary tuberculosis, etc.); 3: history of lobectomy; 4: Subjects had a significant history of clinical circulatory failure; 5: major contraindications to spirometry (history of myocardial infarction, cerebral artery or aortic aneurysm, ophthalmic surgery, hemoptysis); 6: patients with rheumatic diseases; Patients with serious primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system; 7: patients with a history of acute gastrointestinal bleeding within three months; 8: subjects had any active autoimmune disease or history of autoimmune disease 9: congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase did not meet the inclusion criteria, HBV DNA=104/ml, HCV RNA=103/ml); Chronic hepatitis B virus carriers with HBV DNA=2000 IU/ml(=104copies/ml) had to receive antiviral therapy during the trial to be enrolled. 10: the subject is participating in another clinical study or less than 1 month since the end of the previous clinical study; 11: Subjects may have received live vaccine less than 4 weeks before or during the study; 12: pregnant or lactating women; 13: The subjects were intolerant or allergic to the test drugs; 14: patients with heart disease and high blood pressure; 14: Patients with heart disease and hypertension;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function-FEV1;Lung function-FVC;Lung function-FEV1/FVC;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemistry;Blood routine;Urine routine; | — |
Countries
China
Contacts
Public ContactMinLingfeng
Subei People's Hospital
Outcome results
None listed