ENEs
Conditions
Interventions
Treatment group:Surufatinib 150 mg once daily (QD) orally for 3 days,
Etoposide 100 mg/m2 intravenous infusion 1~3 days,
Carboplatin AUC=5, intravenous infusion day 1.
The above dosing regimen was
Sponsors
Shanghat Ninth Peopto's Hospitat , Shanghat JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be enrolled in this study, patients must meet all of the following criteria: 1. Patients voluntarily participate in the study, sign the informed consent, and have good compliance; 2. 18-75 years old (inclusive); 3. Histologically diagnosed patients with locally progressive or initially surgically unresectable neuroendocrine tumors of lung and mediastinal origin; 1) The expression of at least one neuroendocrine marker (CgA, Syn) was positive by immunohistochemistry; 4. The patient must have at least one measurable lesion (RECIST 1.1); 5. Have not received systemic treatment before; 6. ECOG physical condition 0 or 1 score; 7. Expected survival =12 weeks; 8. Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value =1.5×109/L, platelets =100×109/L, hemoglobin concentration =90 g/L); 2) Liver function test (bilirubin =1.5×ULN, AST and ALT=2.5×ULN in the absence of liver metastasis; In case of liver metastasis, AST and ALT=5×ULN); 3) Renal function (serum creatinine =1.5×ULN, or creatinine clearance (CCr)=60 ml/min); 4) Coagulation, International standardized ratio (INR) =1.5×ULN, prothrombin time (PT) = ULN+4 seconds 5) Thyroid function, thyroid stimulating hormone (TSH) = the upper limit of normal (ULN); If abnormal FT3 and FT4 levels should be examined, FT3 and FT4 levels can be selected if normal; 9. Women of childbearing age must have had a negative serum pregnancy test within 7 days prior to treatment and be willing to use a medically approved effective contraceptive (e.g., IUD, contraceptive or condom) during the study period and within 3 months after the last use of the study drug; For male subjects whose partner is a woman of childbearing age, surgical sterilization is required or effective contraception is recommended during the study period and within 3 months after the last study dosing; 10. Urine routine, urine protein < 2+; If urinary protein is =2+, the 24-hour urinary protein quantity must be =1g.
Exclusion criteria
Exclusion criteria: Patients will not be admitted to the study if they meet any of the following criteria: 1. Received the following treatments within 4 weeks of treatment: including but not limited to surgery, chemotherapy, radical radiotherapy, biological targeted therapy, immunotherapy, anti-tumor Chinese medicine therapy, interventional embolization of hepatic artery, liver metastasis cryoablation or radiofrequency ablation of tumor radiation therapy, and other clinical investigational drugs; 2. Previous systematic therapy, including standard first-line chemotherapy, long-acting somatostatin analogists, interferon, PRRT (peptide receptor radionuclide therapy), mTOR inhibitors, or previous anti-VEGF /VEGFR targeted drug therapy, such as solantinib; Or have previously received any of the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or in response to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); 3. Serum potassium, calcium (after ionic or albumin-binding type correction) or magnesium exceed the normal range and have clinical significance; 4. Hypertension that cannot be controlled stably by drugs is defined as: systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg; 5. Gastrointestinal diseases or conditions that the investigator determines may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable gastrointestinal tumors, or other conditions that the investigator determines may cause gastrointestinal bleeding or perforation; 6. Severe bleeding in the past or at present (within 3 months; 30 ml), coughing up blood within 4 weeks > 5 ml of fresh blood) or thromboembolic events (including transient ischemic attacks) within 12 months; 7. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severely unstable angina pectoris, or coronary artery bypass grafting within 6 months of enrollment; Congestive heart failure New York Heart Association (NYHA) Grade 2; Ventricular arrhythmias requiring medical treatment; Left ventricular ejection fraction (LVEF) 1×104 copies /mL or > 2000 IU/ml); 13. Known hepatitis C virus infection (HCV) and HCV RNA positive (> 1×103 copies /mL), or other hepatitis, cirrhosis]; 14. Surgical procedures were performed within 28 days prior to inclusion in the study (except biopsy or surgical incision was not completely healed); 15. Brain metastases or spinal cord compression that have not been treated with surgery or radiation, or previously treated brain metastases or spinal cord compression with no clinical imaging evidence of stabl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| RFS;OS;DCR;ORR;R0 removal rate;MPR;Safety; | — |
Countries
China
Contacts
Public ContactJi Guangyu
Shanghat Ninth Peopto's Hospitat , Shanghat JiaoTong University School of Medicine
Outcome results
None listed