non-small cell lung cancer
Conditions
Interventions
Experimental group:Sintilimab and Anlotinib Hydrochloride Capsules
Sponsors
Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Advanced (stage IV) NSCLC confirmed by histology or cytology according to the 8th edition of the TNM staging of lung cancer by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification; 2. NSCLC with positive epidermal growth factor receptor (EGFR) gene mutation; 3. The 50% analysis of PD-L1 expression was determined by the PD-L1 assay kit (clone number: 22C3); 4. EGFR-TKI was performed, and the efficacy was evaluated as PD; 5. Must have at least one evaluable lesion according to RECIST criteria (tumor diameter 2.0-5.0 cm on spiral CT, metastatic lesions: unilateral = 12 weeks; 9. Adequate blood function: absolute neutrophil count (ANC) >= 2 x 10^9/L and platelet count >= 100 x 10/L and hemoglobin >= 9 g/dL; 10. Sufficient liver function: total bilirubin = 60 mL/min; 12. Women with an intact uterus must have a negative pregnancy test result within 28 days prior to enrollment in the study (unless it has been 24 months of amenorrhea). If the pregnancy test is more than 7 days after the first dose, a urine pregnancy test is required for verification (within 7 days before the first dose); 13. Sign the informed consent form (informed consent forms require approval by an independent ethics committee and informed consent from patients prior to starting any substantial trial procedures).
Exclusion criteria
Exclusion criteria: 1. Histopathologically non-NSCLC patients and/or TNM stage non-IV patients; 2. Patients with original serious heart disease, including: history of coronary heart disease, congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease and intractable hypertension; 3. Pregnant or lactating patients; 4. The patient (male or female) has the possibility of childbearing but is unwilling or fails to take effective contraceptive measures; 5. At the same time accept the experimental treatment of other clinical studies (in the treatment period of the clinical study); 6. Known to be allergic to drugs that may be used; 7. There is evidence of other diseases, abnormal neurological or metabolic functions, abnormal physical examination or abnormal laboratory tests that may be contraindicated to the study drug or may cause a high risk of treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Overall Survival;objective response rate;Adverse Event; | — |
Countries
China
Contacts
Public ContactLi Luzhen
Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine
Outcome results
None listed