Lung cancer and tuberculosis
Conditions
Interventions
single arm(PD1 inhibitor):None
Sponsors
Guangzhou Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1, age 18-75 years old, gender is not limited; 2. Histopathologically confirmed locally advanced, inoperable stage IIIB or IV non-small cell lung cancer with negative driver gene test results; At the same time according to etiology and radiology confirmed: active pulmonary tuberculosis; 3. Patients who have not undergone immunotherapy or systemic therapy; 4. Eastern Cancer Collaboration Group Physical Status Score (ECOG PS): 0-1 points; 5. Based on the Response Evaluation Criteria in Solid Tumors version (RECIST 1.1), there are >= 1 measurable target lesions; 7. Peripheral blood count and liver and kidney function are within the following allowable ranges (tested within 7 days before the start of treatment):White blood cell (WBC) >= 3.0×10^9/L or absolute neutrophil count (ANC) >= 1.5×10^9/L; - Hemoglobin (HGB) >= 80 g/L; - Platelet (PLT) >= 100×10^9/L; - Liver transaminases (AST, ALT) < 3.0 times the upper limit of the normal range; - Total bilirubin (TBIL) < 2 times the upper limit of the normal range; - Creatinine (CREAT) < 1.5 times the upper limit of the normal range; 8. Patients of childbearing age must take effective contraceptive measures; 9. Patients must sign an informed consent form before enrollment;
Exclusion criteria
Exclusion criteria: 1. Malignant tumors other than late stage non-small cell lung cancer with negative driver genes, as well as tuberculosis patients other than active tuberculosis (including latent and old tuberculosis); 2. Previously exposed to therapeutic anti-cancer vaccines; Previously exposed to T-cell co stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies; 3. Participated in clinical trials of other drugs within 4 weeks prior to the start of the study; 4. Individuals who are known to be allergic to the research drug components involved in the study; 5. History of other malignant tumors within the past 5 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 6. Pregnant or lactating women; 7. There are active and unstable systemic diseases, such as active infections, uncontrolled hypertension, heart failure (NYHA grade>=II), unstable angina, and acute coronary syndrome; Severe arrhythmia, severe liver, kidney or metabolic diseases, HIV infected individuals; 8. Patients with drug abuse, drug abuse, long-term alcoholism and positive hepatitis B virus or HIV test; 9. Individuals with pre-existing interstitial lung disease (ILD), drug-induced ILD, or active ILD requiring systemic corticosteroid or immunosuppressive therapy; 10. Patients with incomplete bone marrow function and important organ function reserve; 11. The researchers believe that the subjects may not be able to complete this study or may not be able to comply with the requirements of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 13/1000 13/1000 real-time translation of the incidence rate of serious adverse events at or above level three; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;progression-free survival;Adverse Event Rate;Quality of Life Rating;Duration of response;verall Response Rate,ORR; | — |
Countries
China
Contacts
Public ContactShan su
Guangzhou Chest Hospital
Outcome results
None listed