Neuroendocrine Tumors
Conditions
Interventions
Experimental group:Surufatinib+Octreotide LAR
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand this research and sign the informed consent voluntarily; 2. Aged 18 to 75 years (including the boundary value, calculated on the day of signing the informed consent), both male and female; 3. Histologically or cytologically diagnosed unresectable locally advanced or distant metastases with pathological classification of low- and intermediate-grade G1/G2 NETS (limited to gastroenteropancreatic origin); 4. The patient must have at least one measurable lesion (RECIST 1.1); 5. All patients must provide tumor samples for central pathology review to verify whether the patient's diagnosis and grading meet the inclusion criteria; 6. Untreated functionally active or inactive neuroendocrine tumor/cancer patients; 7. ECOG physical condition 0 or 1 point; 8. Expected survival >= 12 weeks; 9. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors within 14 days before enrollment is not allowed): (1) Absolute neutrophil count >=1.5x10^9/L; (2) Platelets>=100x10^9/L; (3) Hemoglobin>=9g/dL; (4) Serum albumin>=3g/dL; (5) Bilirubin= 60ml/min. 10. Male or female patients with reproductive potential voluntarily use effective contraceptive methods during the study period and within 6 months of the last study medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause, or sterilization (eg, hysterectomy, bilateral adnexectomy, or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1.Prior treatment with Octreotide,Surufatinib,or other antiangiogenic drugs were used ; 2.Prior antitumor therapy with chemotherapy, radical radiation therapy ,biological immunotherapy,targeted therapy traditional chinese medical treatment (TCM treatment with clear anti-tumor indications in the instructions can also be included after 1-week washout period)within 4 weeks. 3.Prior participation in other clinical trials not approved or listed in China within past 4 weeks 4.Prior major surgery within past 4 weeks (diagnostic surgery excluded); 5.International standardized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5xULN; 6.Clinically significant severe electrolyte abnormality judged by investigator ; 7.Hypertension that is not controlled by the drug, and is defined as: SBP>=140 mmHg and/or DBP>=90 mmHg; 8.Currently suffering from poorly controlled diabetes (after regular treatment, fasting plasma glucose concentration >=10mmol/L); 9.The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally; 10.Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis or unresected tumor, or other conditions determined by the investigator that may cause gastrointestinal bleeding and perforation; 11.Evidence of bleeding tendency or history within 3 months, or thromboembolic event (including a stroke event and/or a transient ischemic attack) occurred within 12 month; 12.Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within the first 6 months of enrollment;New York Heart Association (NYHA) grade >2 for congestive heart failure;Ventricular arrhythmias requiring medical treatment;LVEF (left ventricular ejection fraction) =CTCAE2 infection); 15.Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml); 16.Evidence with active CNS disease or previous brain metastases; 17.The toxicity associated with previous anti-tumor treatment has not recovered to =2+, and the 24-hour urine protein volume >1.0g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival; | — |
Countries
China
Contacts
Public ContactSun Xiaofeng
Jiangsu Cancer Hospital
Outcome results
None listed