Neuroendocrine Tumor
Conditions
Interventions
Experimental group:Surufatinib combined CAPTEM(Capecitabine plus Temozolomide)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients have been fully informed about this study and voluntarily signed the informed consent form; 2.Aged 18-80 years old; 3.Histopathologically confirmed patients with locally advanced unresectable/metastatic well differentiated (Grade 2 or Grade 3) gastroenteropancreatic NETs, as well as typical and atypical lung and thymic carcinoid tumors, who meet the following requirements: well differentiated, mitotic rate =2/high power field [HPF] and/or Ki-67 proliferation index =3%. If the mitotic rate and Ki-67 index of the same tumor correspond to different grades, the higher grade should be followed; 4.Previously received =3 lines of systemic anti-tumor therapies, which can be somatostatin analogs, interferon, PRRT (peptide receptor radionuclide therapy), sunitinib, mTOR inhibitors or chemotherapy; treatment-naïve patients who cannot receive or refuse the above treatments can also be enrolled; 5.Patients have measurable lesions (according to RECIST 1.1 criteria); 6.ECOG performance status 0 or 1; 7.Expected survival >24 weeks; 8.Male or female patients with reproductive potential agree to use effective contraceptive methods during the study and 90 days after the last study drug administration, such as dual barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered to have reproductive potential unless the female patient has undergone natural menopause, surgical menopause, or sterilization surgery (such as hysterectomy, bilateral salpingo-oophorectomy, or radiotherapy to the ovaries, etc.).
Exclusion criteria
Exclusion criteria: If any of the following criteria is met, the patients must be excluded: 1.Well differentiated G1 neuroendocrine tumor and poorly differentiated neuroendocrine carcinoma; 2.The functional NET should be accompanied by the use of long-acting somatostatin analogues, such as insulinoma, gastrinoma, glucagon tumor, somatostatin tumor, ACTH tumor, VIP tumor, with carcinoid syndrome, Zooey syndrome or disease specific active symptoms; 3. Patients who have been treated with surufatinib or CAPTEM regimen in the past and have disease progression within 4 cycles of medication; 4. Absolute neutrophil count (ANC)3X ULN, regardless of symptomatic treatment; 7. Serum creatinine = 1.5 times ULN or creatinine clearance rate1.5 times ULN or partially activated prothrombin time (APTT)>1.5 times ULN. 10. The serum potassium ion exceeds the normal range and has clinical significance; Serum calcium (ionic type or albumin binding type after correction) or magnesium exceeds the normal range and has clinical significance; 11. Hypertension that cannot be controlled stably by the drug is defined as: systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg; Previous hypertensive crisis or hypertensive encephalopathy history. 12. The investigator judges that there may be digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases or active bleeding of unresectable digestive tract tumors, or other conditions that the investigator judges may cause gastrointestinal bleeding or perforation; 13. Serious bleeding (>30ml bleeding within 2 months), hemoptysis (>5ml fresh blood within 4 weeks) occurred in the past or present or thromboembolism (including transient ischemic attack) within 12 months; 14. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure New York Heart Association (NYHA) grade>2; Ventricular arrhythmias requiring medication; LVEF<50%; 15. ECG showed QTc interval = 480 milliseconds (ms); 16. Other malignant tumors in the past 5 years, excluding skin basal cell or squamous cell carcinoma or cervical carcinoma in situ after radical surgery; 17. Brain metastasis or spinal cord compression without surgery and/or radiotherapy, or brain metastasis or spinal cord compression with previous treatment, but no clinical imaging evidence shows that the condition is stable; 18. Pregnancy (positive pregnancy test before medication) or women who are breastfeeding. 19. Any other disease, metabolic abnormality, physical examination abnormality or laboratory examination abnormality, according to the judgment of the investigator, it is reasonable to suspect that the patient has a certain disease or state that is not suitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rates;Disease control rate;Duration of response;Overall survival; | — |
Countries
China
Contacts
Public Contactwangwei
Sun Yat-sen University Cancer Center
Outcome results
None listed