non-small cell lung cancer
Conditions
Interventions
experimental group :Sintilimab and Bevacizumab
Sponsors
Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with one or more high-risk GGNs in lung CT scan that cannot be operated or SBRT at the same time, or at least one high-risk GGN (GGN size >=8mm and internal solid component diameter > 5mm) remaining after partial surgical resection that are at risk of reoperation or SBRT; 2. Aged >=18 years, ang = 90 g/L (no blood transfusion within 14 days), Neutrophils count > 1.5 x 10^9 /L, Platelet count >= 75x10^9/L; (2) Biochemical examination: Total bilirubin = 60 mL /min (Cockcroft-Gault formula),Serum albumin >= 30g/dL; (3) No life-threatening electrolyte abnormalities; (4) Thyroid stimulating hormone (TSH)= 50%; (7) Good coagulation function is defined as the international standardized ratio (INR) or prothrombin time (PT) = 24 months; 8. Contraceptive requirements: the serum pregnancy test of women of childbearing age was negative within 72 hours before the first medication.Subjects of childbearing age and male subjects whose partners were women of childbearing age were treated with high-efficiency method contraception during the study period and for 180 days after the last administration of the study drug; 9. Good compliance, family members agree to cooperate with the survival follow-up; 10. Blood routine, liver and kidney function, hepatitis index, electrolyte, coagulation, thyroid function, ECG, abdominal B ultrasound, chest X ray were all normal; 11. The patient signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis; Subjects with vitiligo or asthma that had been in complete remission during childhood were enrolled as adults without any intervention;Asthmatic subjects requiring bronchodilators for medical intervention were not included); 2. Patients are taking immunosuppressive, systemic, or absorbable topical hormonal therapy for immunosuppressive purposes (dose >; 7.5mg/d prednisone or other equal-efficacy hormone) and continued to be used within 2 weeks before enrollment; 3. Severe allergic reactions to other monoclonal antibodies; 4. Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 5. Patients with a history of unstable angina pectoris;Patients newly diagnosed with angina pectoris within 3 months before screening or patients with myocardial infarction within 6 months before screening; 6. Resting electrocardiogram (ecg) in rhythm, conduction, or form of significant and severe symptoms are difficult to control on exceptions, such as complete left bundle branch block, II degrees above heart block, ventricular arrhythmia or atrial fibrillation, New York heart association class II or higher cardiac insufficiency; 7. Routine urine indicated urinary protein >= ++ and confirmed 24-hour urinary protein quantification > 1.0 g; 8. Long-term unhealed wounds or incomplete healed fractures; 9. Patients with abnormal coagulation function and bleeding tendency (14 days before randomization must be satisfied: INR is within the normal range without the use of anticoagulants);Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs;The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR 38.5 degree C; 13. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc.; 14. Having a history of psychotropic substance abuse and unable to abstain from it or having mental disorders; 15. Patients had prior or coexisting malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 16. Patients may receive other systemic antitumor therapies during the study period; 17. Patients have previously received other PD1 antibody therapy or other immunotherapy against PD/PDL1; 18. Live vaccine was given less than 4 weeks before or possibly during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Major pathological remission;Pathological complete remission;2-year progression-free survival rate;2-year sustained remission rate; | — |
Countries
Chian
Contacts
Public ContactXu Lin
Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University
Outcome results
None listed