extensive small cell lung cancer
Conditions
Interventions
Immunotherapy + targeted therapy + chemotherapy:sintilimab, 200mg, D1,Q3W
surufatinib,250mg, QD,Q3W
VP-16,100mg/m2,D1-3,Q3W
CBP AUC5-6,or DDP 75mg/m2,D1,Q3W
Immunotherapy + targeted therapy:sintilimab, 200mg, D1,Q3W
Targeted therapy + chemotherapy:surufatinib,250mg, QD,Q3W
Immunotherapy + chemotherapy:sintilimab, 200mg, D1,Q3W
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age =18 years old; 2.Histopathological diagnosis of extensive small cell lung cancer; 3.No prior treatment for extensive small cell lung cancer; 4.ECOG ps score 0 or 1; 5.Expected survival=12 weeks; 6.Have at least one measurable lesion according to RECIST 1.1; 7.Adequate organ and bone marrow function; (1)white blood cells=3.5 x 10^9/L neutrophils=1.5 x 10^9/L platelet count=125 x 10^9/L hemoglobin=90g/L (2)INR=1.5 x ULN and APTT=1.5 x ULN (3)serum bilirubin=1.5 x ULN for patients without liver metastasis:ALT/AST/ALP=2.5 x ULN for patients with liver metastasis:ALT/AST/ALP =5 x ULN (4)serum creatinine=1.5 x ULN and CCr>60mL/min (5)LVEF = 50% 8.Fully understand this study, voluntarily participate, and sign informed consent; 9.Use contraception during treatment or 6 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Prior use of surufatinib or other antiangiogenic drugs; 2. Prior use of sintilimab or any other antibody treatment involving anti-PD-1, anti-PD-L1/L2, or anti-CTLA4 or other immunotherapies; 3. Patients with symptomatic brain metastases; 4. Radiographic examination (CT or MRI) showing significant lung void or necrotic tumor; 5. Patients with brain or central nervous system metastases, including leptomeningeal metastasis, or brain or leptomeningeal lesions indicated by CT/MRI; 6. Patients participating in other clinical studies within 4 weeks before the first dose(excluding non-intervention studies); 7. Patients who received chemotherapy, radiotherapy, or other experimental anticancer therapy (excluding bisphosphonates) within 4 weeks before the first dose. Patients who had previously received local radiation therapy were eligible if they met the following criteria: the end of radiotherapy was more than 4 weeks prior to the start of the study (brain radiation was more than 2 weeks prior); In addition, the target lesions selected for this study were not in the radiotherapy area, or if the target lesions were in the radiotherapy area but had been confirmed to progress. 8. Patients suffered from tumors other than small cell lung cancer within 5 years; 9. Patients with active, known, or suspected autoimmune diseases, including a history of allogeneic organ;transplantation, allogeneic hematopoietic stem cell transplantation, HIV-positive or acquired immune deficiency syndrome (AIDS); 10. Active or previously documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis); 11. Nonremission toxicity from prior treatment, above grade 1 of CTC AE(4.0), excluding alopecia; 12. Abnormal coagulation, with a bleeding tendency or receiving thrombolytic and anticoagulant therapy, clinically significant hemoptysis occurred within 3 months before enrollment, clinically obvious bleeding symptoms or bleeding tendency, such as gastrointestinal bleeding and hemorrhagic gastric ulcer, baseline fecal occult blood + +, unhealed wound, ulcer or fracture within 4 weeks before grouping; 13.Urine protein =+ +, or urine protein = 1.0g within 24 hours; 14. Uncontrolled hypertension; 15. Patients with serious cardiovascular disease: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; grade III to IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50% according to NYHA criteria; 16. NCI-CTCAE grade II or above peripheral neuropathy, except as a result of trauma; 17. Interstitial lung disease, uncontrolled medium to large serous luminal effusion (including pleural effusion, ascites, and pericardial effusion) after aspiration, exacerbation of chronic obstructive pulmonary disease requiring intravenous antibiotic treatment within 28 days, active lung infection, and/or acute bacterial or fungal respiratory disease; 18. Significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 19. Venous thromboembolism events occurred within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, pulmonary embolism, etc.; 20. Received live or attenuated vaccine within 30 days before the first dose of sintilimab, or planned to receive the live or attenuated vaccine during the study period; 21. Patients with a k
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| disease control rate(DCR);progression-free survival(PFS);overall survival(OS);Safety;Psychological scale: GAD-7?PHQ-9?SDS/SAS?SSS;Nutrition assessment Scale; | — |
Primary
| Measure | Time frame |
|---|---|
| objective remission rate(ORR); | — |
Countries
China
Contacts
Public ContactLiu Yibing
Fourth Hospital of Hebei Medical University
Outcome results
None listed