pancreatic neuroendocrine tumor
Conditions
Interventions
Experimental group1:Surufatinib+Capecitabine + Temozolomide
Experimental group2:Surufatinib+Etoposide+cisplatin
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have a full understanding of this study and voluntarily sign the informed consent form (the informed consent form must be signed before any special procedures of the trial are performed); 2. Aged 18 to 75 years (inclusive); 3. Patients with locally advanced or distantly metastatic pancreatic neuroendocrine tumor (PNET) confirmed by histopathological diagnosis as unresectable; 4. The pathological examination has a clear Ki67 index and the Ki67 index is greater than 10%; 5. No previous systemic treatment; 6. ECOG physical condition 0 or 1 point (Appendix 1); 7. It is clear that there are measurable lesions that meet the requirements of the Response Evaluation Criteria for Solid Tumors (RECIST 1.1); 8. Have sufficient bone marrow, liver and kidney functions, and meet the following requirements for laboratory tests within 7 days before the first administration: (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L and hemoglobin >= 90 g/L (no blood transfusion, blood products, no use of blood within 14 days before the laboratory test) granulocyte-colony stimulating factor or other hematopoietic stimulating factor correction); (2) Serum total bilirubin = 50 mL/min (calculated according to the Cockcroft-Gault formula, see Annex 2); (5) Urine routine examination shows that the urine protein is less than 2+; if the urine protein is >=2+, the 24-hour urine protein quantitative should be less than 1 g; (6) International normalized ratio (INR) = 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Neuroendocrine carcinoma and small cell carcinoma; 2. Functional NETs that require concomitant use of long-acting somatostatin analogs to control symptoms, such as insulinoma, gastrinoma, glucagonoma, somatostatinoma, ACTH tumor, VIP tumor, with carcinoid syndrome , Zollinger syndrome or active symptoms specific to the disease; 3. Untreated chronic hepatitis B patients or HBV carriers with hepatitis B virus (HBV) DNA >= 500 IU/mL, or patients with active hepatitis C virus (HCV); 4. The toxicity related to previous anti-tumor therapy has not recovered to = 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 13. The patient currently has any disease or condition that affects the absorption of the drug, or the patient cannot be administered orally; 14. Received a strong CYP3A inducer or inhibitor within 1 week or 5 half-lives (whichever is longer) before the first dose (Appendix 3); 15. The patient currently has gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator; 16. Patients with evidence or history of thrombosis or obvious bleeding tendency within 2 months before the first medication (bleeding > 30 mL within 2 months, hematemesis, melena, blood in the stool), hemoptysis (fresh blood > 5 mL within 4 weeks) ; 17. Arterial thrombosis or deep vein thrombosis occurred within 6 months before the first medication; or stroke event and/or transient ischemic attack occurred within 12 months; 18. Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass surgery within 6 months before the first drug; congestive heart failure New York Heart Association (NYHA) classification >= 2 grade; left vent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;2year Disease free survival rate;Tumor regression rate;3year overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactKe Nengwen
West China Hospital, Sichuan University
Outcome results
None listed