| Eligibility |
Inclusion Criteria:
- Age = 18 years, no gender limit;
- Histological or cytological diagnosis of stage IV non-small cell lung cancer(NSCLC)
- The patients joined the study voluntarily and signed an informed consent form (ICF).
They had good compliance and cooperated with follow-up.
- Patients with advanced NSCLC who have received one or two systemic treatments, and
those who are unwilling to accept or cannot tolerate systemic chemotherapy can also be
enrolled. If it is a driver gene mutation-positive (EGFR, ALK) patient, it must be
accepted after receiving the corresponding targeted therapy resistance or intolerable
toxicity, No secondary susceptible mutations were eligible for enrollment.
- Has at least five disseminated lesions for SBRT , and measurable lesion that meets the
RECISTv1.1 standard?
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Status
- The expected survival time = 3 months;
- The functions of important organs meet the following requirements (no blood components
and cell growth factors are allowed to be used 2 weeks before the start of the
research treatment): Absolute Neutrophil Count (ANC) =1.5×10 E+9/L, Hemoglobin (HB)
=9g/dL, Platelets (PLT)=90×10 E+9/L, Serum Albumin (ALB)=2.8g/dL, Total Bilirubin
(TBIL) =1.5 ULN, ALT?AST=2.5 UILN(If abnormal liver function is caused by liver
metastasis, =5 ULN), Serum creatinine sCr=1.5 ULN, endogenous creatinine clearance
=50ml/min (Cockcroft-Gault formula) , Normal thyroid function;
- For female subjects of childbearing potential, a serum pregnancy test should be
performed within 7 days prior to the administration of the first study intervention
(study drug, radiation therapy) and have a negative result. Subjects are required to
agree to use highly effective contraception and continue until at least 120 days after
discontinuation of trial treatment
Exclusion Criteria:
- The lesion has received prior radiotherapy and is not suitable for SBRT;
- Currently participating in interventional clinical research and treatment, or
receiving other research drugs or treatment with research equipment within 4 weeks
before the first administration;
- Imaging (CT or MRI) shows evidence of tumour invasion of large blood vessels or poorly
demarcated blood vessels or the presence of cavities and necrotic lesions in the
lungs;
- With active bleeding or perforation or a hereditary or acquired bleeding tendency
present, with a daily haemoptysis of =2.5mL in the 3 months prior to screening.
- Suffer from active autoimmune diseases that require hormone or immunomodulatory
treatment;
- Have received anti-tumor monoclonal antibodies (mAb) within 4 weeks before using the
study drug for the first time, or the adverse events caused by the previously received
drug have not recovered (ie = grade 1 or reached the baseline level). Note: Except for
subjects with = Grade 2 neuropathy or = Grade 2 hair loss, if the subject has
undergone major surgery, the toxic reaction and/or complications caused by the
surgical intervention must be fully recovered before starting treatment;
- Patients with multiple factors that affect oral medications (eg, inability to swallow,
chronic diarrhea, and intestinal obstruction).
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated
drainage.
- Suffer from acute or chronic infectious diseases, such as hepatitis B, hepatitis C,
tuberculosis, and HIV;
- Suffer from uncontrolled clinical symptoms or diseases of the heart, such as:(1) Heart
failure above NYHA II; (2) Unstable angina pectoris; (3) Myocardial infarction
occurred within 1 year; (4) Patients with clinically significant supraventricular or
ventricular arrhythmia requiring clinical intervention;
- Suffer from high blood pressure and cannot be well controlled by antihypertensive
medication (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg);
- Live vaccines have been vaccinated within 4 weeks before the first use of the study
drug.
- Active or previously documented inflammatory bowel disease (eg, Crohn's disease,
ulcerative colitis, or chronic diarrhea).
- Diagnosed as immunodeficiency or receiving systemic glucocorticoid therapy or any
other form of immunosuppressive therapy (dose >10mg/day prednisone or other equivalent
therapeutic hormones), and still within 2 weeks before the first dose continue to use.
- Have a history of active pulmonary tuberculosis. In patients suspected of having
active TB, examination of chest X-ray, sputum, and exclusion by clinical symptoms and
signs are required.
- Has an active infection requiring systemic treatment.
- Previous history of interstitial lung disease, drug-induced interstitial disease,
radiation pneumonitis requiring hormone therapy, or any active interstitial lung
disease with clinical evidence.
- Past history of clear neurological or psychiatric disorders.
- The investigator judged other situations not suitable for inclusion in this study.
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