Lung adenocarcinoma
Conditions
Interventions
Intervention group:Sintilimab + bevacizumab + pemetrexed + carboplatin/cisplatin
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed liver metastatic (stage IV) lung adenocarcinoma based on the eighth edition of the AJCC staging system. 2. No common lung cancer driver genes (EGFR, ALK, ROS1 mutations-). 3. At least one measurable target lesion. 4. ECOG PS: 0-1. 5. Life expectancy greater than 3 months. 6. Absolute neutrophil count (ANC) =1.5 × 109/L, platelets =100 × 109/L, hemoglobin =90g/L. 7. International normalized ratio (INR) or prothrombin time (PT) =1.5×ULN. 8. Activated partial thromboplastin time (aPTT) =1.5×ULN. 9. Serum total bilirubin =1.5×ULN. 10. Patients with AST and ALT = 5×ULN. 11. Able to provide written informed consent (ICF) and understand and agree to comply with the study requirements and assessment schedule. 12. Male or female aged 18-75 years old when signing the ICF. 13. Patients of childbearing potential must be willing to take highly effective contraceptive measures during the study and within 120 days after the last dose of the experimental drug.
Exclusion criteria
Exclusion criteria: 1. Patients who have received immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4 therapy or anti-angiogenic therapy such as bevacizumab and anlotinib. 2. Patients who have received systemic platinum-containing double-drug chemotherapy as advanced treatment. 3. Patients who received other approved systemic anticancer treatments or systemic immunomodulators (including but not limited to interferon, interleukin 2 and tumor necrosis factor) 4 weeks before the first dose. 4. Patients with refractory pleural effusion or ascites, such as pleural effusion or ascites that requires puncture drainage within 2 weeks before the first dose. 5. Active leptomeningeal disease or brain metastasis, if there are central nervous system symptoms, requires interventional treatment (including but not limited to radiotherapy, intracranial pressure reduction therapy, etc.). 6. Allergy to any study drug or excipient. 7. Creatinine clearance ); b. Patients with positive HCV RNA testing (HCV RNA testing is only performed on patients with positive hepatitis C virus antibody). 9. Patients with active autoimmune diseases that require systemic treatment and are considered by the investigator to have an impact on the study regimen. 10. Patients who have long-term and large-scale use of hormones or other immunosuppressants and are considered by the investigator to have an impact on the study regimen. 11. Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection, etc.: a. Severe infection requiring hospitalization within 4 weeks before the first dose, including but not limited to complications of infection, bacteremia or severe pneumonia; b. Oral or intravenous antibiotic treatment within 2 weeks before the first dose. 12. History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. 13. Known human immunodeficiency virus (HIV) infection. 14. Any major surgery requiring general anesthesia within 28 days before the first dose. 15. The presence of conditions that are not conducive to the administration of the study drug, or may affect the interpretation of the results, or cause the patient to have treatment complications (including but not limited to interferon, interleukin 2 and tumor necrosis factor).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Duration of remission, DOR; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Countries
China
Contacts
Public ContactLijuan Chen
Henan Cancer Hospital
Outcome results
None listed