Pituitary neuroendocrine tumors
Conditions
Interventions
Treatment group:Surufatinib monotherapy
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Have fully understood this study and voluntarily sign the informed consent form; 2.Patients with histologically or cytologically confirmed pituitary neuroendocrine tumors (all subtype permitted); 3.Patients must have at least one measurable lesion (RECIST 1.1); 4.No radiotherapy after surgery and the presence of residual tumors or follow-up after radiotherapy suggest that the tumor is still progressing; 5.ECOG PS 0-1; 6.Expected survival >= 12 weeks; 7.Blood test (without blood transfusion within 14 days) 1) Absolute neutrophil value>=1.5×109/L, platelet >=100×109/L, hemoglobin concentration>=9g/dL; 2) Liver function tests (aspartate aminotransferase and glutamate aminotransferase =80ml/min); 4) Myocardial markers (troponin T<1×ULN, myoglobin<2×ULN, CK-MB mass<2×ULN, pro BNP<1×ULN); 8.Male or female patients of childbearing potential voluntarily use effective contraceptive methods, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study medication. All female patients will be considered of childbearing potential unless the female patient is naturally postmenopausal, has undergone artificial menopause, or has undergone sterilization (e.g., hysterectomy, bilateral adnextomy, or radioactive ovarian irradiation, etc.); 9.18-70 years old (including cut-off value);
Exclusion criteria
Exclusion criteria: 1.Patients who have received prior treatment with surufatinib or other anti-angiogenic drugs; 2.KPS 1.5 or partially activated prothrombin time (APTT) >1.5× ULN; 4.Clinically significant electrolyte abnormalities as judged by the investigator; 5.Presence of hypertension that has not been controlled by medication, as prescribed as: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 6.Poor glycemic control (FBG 10 mmol/L); 7.Patient has any current disease or condition that affects drug absorption, or patient has difficulty swallowing and cannot take surufatinib orally; 8.Patients currently have active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator; 9.Patients with significant evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, with hematemesis, black feces, blood in the stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 10 months; 10.Clinically significant cardiovascular disease, including but not limited to the following: acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) grade >2; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) 1×104 copies/mL or >2000 IU/ml); 3) Known hepatitis C virus infection (HCV) with positive HCV RNA (>1×103 copies/mL), or other hepatitis or cirrhosis; 13.Patients with persistent toxicity due to any prior anti-tumor therapy that has not recovered to grade =2, but with alopecia, lymphopenia of any grade are allowed to participate in this study; 14.Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 15.Blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment; 16.In the opinion of the investigator, the study participant has any abnormal clinical or laboratory tests or other reasons that make him unsuitable for participation in this clinical study; 17.Those who had a urine protein = 2 and a 24-hour urine protein quantitative > 1.0g;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 48-week PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Progression free survival;Safety;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhao Yao, Huang Ruofan
Huashan Hospital, Fudan University
Outcome results
None listed