Brain Metastases from Lung Cancer
Conditions
Interventions
Group XG0501 :XG0501 combined with standard therapy
Sponsors
Henan Provincial People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients who are able to voluntarily sign the informed consent form, participate in this study, have good compliance, and are willing to comply with follow-up; 2.Aged >=18 years; 3.ECOG performance status 0–2; 4.Life expectancy >= 3 months; 5.Histologically confirmed non-small cell lung cancer (NSCLC) and eligible for anti-PD-1/PD-L1 therapy; 6.Radiologically diagnosed with brain metastases, and with at least one measurable lesion according to RECIST 1.1; 7.Adequate hematologic and organ function; 8.Agreement to use contraceptive measures (females of childbearing potential or males with female partners of childbearing potential).
Exclusion criteria
Exclusion criteria: 1.Immunodeficiency disorders including positive HIV test, or other acquired or congenital immunodeficiency diseases, history of organ transplantation; 2.Intracranial metastatic lesions with size, location, etc., not suitable for local injection therapy; 3.Pregnancy and lactation; 4.Subjects with neutralizing antibody titer against AAV6 capsid in serum >1:2000; 5.Other subjects judged by the investigator to be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Signs;Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free of survival;Lesion size; | — |
Countries
China
Contacts
Public ContactMeiyun Wang
Henan Provincial People’s Hospital
Outcome results
None listed