Lung adenocarcinoma
Conditions
Interventions
The experimental group:FSRT + Sintilimab
Sponsors
The First People's Hospital of Lianyungang
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients volunteered to participate in this study and signed informed consent; 2. Aged >=18 years old, male or female; 3. Pathologically confirmed lung adenocarcinoma, patients with brain oligomerization of lung adenocarcinoma confirmed by enhanced MRI had at least one measurable lesion as target lesion (by RECIST V1.1); 4. ECOG 0~1; 5. Expected survival >=12 weeks; The function of vital organs meets the following requirements (no blood components, cell growth factors or other corrective therapy drugs are recommended 14 days before treatment): The absolute count of neutrophils >=1.5x10^9/L; Platelet >=80x10^9/L; Hemoglobin >=90 g/L; Serum albumin >=30g/L; Thyroid stimulating hormone (TSH)<=1 ULN(IF abnormal, FT3 and FT4 levels should be measured at the same time; if NORMAL, FT3 and FT4 levels can be included in the group); Bilirubin <=1.5 ULN(within 7 days before the first administration); ALT and AST<=1.5 ULN (within 7 days before the first medication); Serum creatinine <=1.5 ULN; 6. Fertile female subjects shall undergo a urine or serum pregnancy test within 72 hours prior to the first study drug administration and prove negative, and must be non-lactating and shall be willing to use an effective method of contraception between the trial period and 3 months after the last study administration of Sintlimab. For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of Sintlimab.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism;Patients with vitiligo;Asthma is fully alleviated in childhood and can be included without any intervention in adulthood;Patients with asthma requiring a bronchodilator for medical intervention are not included.) Patients are receiving immunosuppressive or systemic hormone therapy for immunosuppression purposes (dose>10mg/d of prednisone or other therapeutic hormones) and continued use within 2 weeks prior to enrollment; 2. Severe allergic reaction to monoclonal antibody and its components; 3. Having high blood pressure that cannot be well controlled by antihypertensive drug therapy (SYSTolic blood pressure >=140mmHg or diastolic blood pressure >=90 mmHg); 4. Clinical symptoms or diseases of the heart that cannot be well controlled, such as: NYHA2 grade or above heart failure, unstable angina pectoris, myocardial infarction occurred within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, QTc>450ms(male); QTc>470ms(female); 5. Urine routine indicated urinary protein >=++ and confirmed 24-hour urinary protein amount>1.0 g; 6. Has undergone brain surgery or radiation; Patients who had previously received radiotherapy, chemotherapy, hormone therapy, surgery, and were studied less than 2 weeks before medication after completion of treatment (last medication);Molecular targeted therapies (including other oral targeted drugs for clinical trials) are the first to be studied. Patients with 5 drug half-lives, or adverse events due to previous treatment (except hair loss) did not return to =38.5 degree C within 7 days before medication, or white blood cell count at baseline>15 x 10^9/L; Or suppurative sex and chronic infection, the wound does not heal; 8. For patients with bone metastasis, palliative radiotherapy area received in the 4 weeks prior to study participation of 5% bone marrow region; 9. The patient had received anti-PD-1, anti-PD-L1 and anti-PD-L2 treatment in the past; 10. Pregnant or lactating women, or fertile women who do not use contraception; 11. Concurrent patients with other malignant tumors; 12. Patients also participating in other clinical trials; 13. HIV positive; HCV positive; HBsAg or HBcAb positive patients were simultaneously detected with positive HBV DNA copy number (quantitative detection limit was 500IU/ mL); 14. Those who received live vaccination within four weeks of the commencement of treatment; 15. Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, according to the investigator, may increase the risk associated with study participation or may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial field recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DCR;OS;saftey; | — |
Countries
China
Contacts
Public ContactXia Youyou
The First People's Hospital of Lianyungang
Outcome results
None listed