| Eligibility |
Inclusion Criteria:
- 1.The age at the time of signing the informed consent form is 18-75 years old, both
male and female;
- 2.Advanced or metastatic lung squamous cell carcinoma confirmed by histology or
cytology;
- 3.Has not received systemic treatment for the recurrence or metastasis stage in the
past. If you have received neoadjuvant or adjuvant chemotherapy/radiotherapy in the
past, those who have relapsed or metastasized> 6 months from the end of treatment can
be included in the group.
- 4.ECOG PS score: 0-1 points;
- 5.According to the RECIST 1.1 standard, the patient must have at least one measurable
lesion;
- 6.The function of major organs is normal, that is, it meets the following standards:
a) Routine blood examination (under 14 days without blood transfusion and no
hematopoietic stimulating factor drugs for correction): hemoglobin (Hb) =90g/L;
absolute neutrophil count (ANC) ) =1.5×109/L; platelet (PLT) =100×109/L; white blood
cell count (WBC) =3.0×109/L; b) Biochemical examination: alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) =2.5 ×Upper limit of normal (ULN); serum
total bilirubin (TBIL)=1.5×ULN; serum creatinine (Cr)=1.5×ULN or creatinine clearance
=50ml/min; c) coagulation function: activated partial thromboplastin time (APTT),
international normalized ratio (INR), prothrombin time (PT)=1.5×ULN; d) Doppler
ultrasound assessment: left ventricular ejection fraction (LVEF)=50%;
- 7.Expected survival period = 3 months; Women of childbearing age must undergo a
negative pregnancy test (serum or urine) within 14 days before enrollment, and
voluntarily use appropriate methods of contraception during the observation period and
within 3 months after the last administration of the study drug; for men, surgical
sterilization should be performed Or agree to use appropriate methods of contraception
during the observation period and within 3 months after the last administration of the
study drug;
- 8.The patient voluntarily participates and signs the informed consent form (or signed
by the legal representative). It is expected to have good compliance and be able to
cooperate with the research according to the requirements of the plan.
Exclusion Criteria:
- 1) Untreated brain metastases (persons who have previously received treatment for
brain metastases (radiotherapy or surgery), if the images have been confirmed to be
stable for at least 4 weeks before randomization, and systemic hormone therapy has
been discontinued (dose>10mg/day prednisone or Other equivalent hormones), those
without clinical symptoms can be included in the group);
- 2) With meningeal metastasis, spinal cord compression, etc.;
- 3) Patients with pleural effusion, pericardial effusion or ascites who need to be
drained with clinical symptoms, or who have received drainage of serous cavity
effusion for treatment purposes within 2 weeks before randomization;
- 4) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as hepatitis B virus
surface antigen [HBsAg] test results are positive, HBV-DNA = 500 IU/ml and abnormal
liver function; hepatitis C is defined as hepatitis C antibody [HCV-Ab] positive,
HCV-RNA higher than the detection limit of the analysis method and abnormal liver
function) or combined hepatitis B and C co-infection ;
- 5) Suffer from any active autoimmune disease or history of autoimmune disease (such as
interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation,
vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone
replacement) Can be included after treatment)); patients with childhood asthma have
been completely relieved and no intervention is required after adulthood or vitiligo
can be included, and patients who require medical intervention with bronchodilators
cannot be included;
- 6) Severe infection (such as intravenous infusion of antibiotics, antifungal or
antiviral drugs required) within 2 weeks before the first administration, or
unexplained fever >38.5°C during the screening period/before the first administration;
- 7) Arterial/venous thrombosis events that occurred within 6 months before enrollment,
such as cerebrovascular accidents (including temporary ischemic attacks, cerebral
hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- 8) Persons with a history of significant clinical significance of cardiovascular
disease, including but not limited to; (1) Congestive heart failure (NYHA grade> 2);
(2) Unstable angina pectoris; (3) 3 months before signing the ICF Myocardial
infarction occurred within; (4) Any supraventricular arrhythmia or ventricular
arrhythmia that requires treatment or intervention;
- 9) Suffered from or accompanied with other systemic malignancies in the last 5 years,
(except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian
cancer);
- 10) Have received a preventive vaccine or attenuated vaccine within 4 weeks before the
first administration;
- 11) Those who are known to be allergic to any test drug or its excipients;
- 12) Pregnant and lactating patients, and reproductive patients are unwilling to take
effective contraceptive measures;
- 13) Have a clear history of neurological or mental disorders, including epilepsy and
dementia;
- 14) Patients who are unable to swallow the study drug, such as chronic diarrhea
(including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative
colitis) and intestinal obstruction and other factors that affect drug intake and
absorption;
- 15) Other situations that the researcher thinks are not suitable for inclusion.
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