neuroendocrine tumors
Conditions
Interventions
Experimental group:Surufatinib combined with TAE
Control group:Surufatinib
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) NET patients with liver metastasis confirmed by pathological examination (including G1 and G2 grade NET); The location of the primary lesion and whether to undergo surgical resection are not limited; 2) Age range from 18 to 75 years old, regardless of gender; 3) Expected survival time = 12 weeks; 4) The Eastern Cancer Collaborative Group's Physical State Score (ECOG) is 0-2 points; 5) According to imaging and surgical evaluation, the initial liver metastasis is unresectable or cannot tolerate surgery, and the primary lesion has no serious complications (perforation, obstruction, large bleeding that cannot be managed by internal medicine, etc.); 6) According to the RECIST version 1.1 standard, the liver must have at least one measurable objective tumor lesion, with a maximum diameter of = 1cm for spiral CT examination, and = 2cm for conventional CT or magnetic resonance imaging; And it should be conducted within 28 days before enrollment. 7) Subjects must have appropriate organ functions, and the laboratory test results within 1 week before the enrollment meet the following conditions according to the following laboratory test results (no blood transfusion, granulocyte colony-stimulating factor (G-CSF) or other medical support treatment within 14 days before the administration of the study drug): hemoglobin = 90g/L; Platelet (PLT) = 75 × 109/L; White blood cells (WBC) = 3.0 × 109/L; Neutrophils (ANC) = 1.5 × 109 /L ; Total bilirubin (TBI) = 1.5 × Upper limit of normal value (UNL); Blood creatinine (Cr) = 1.5 × Upper limit of normal value; Glutamate transaminase (ALT), cereal grass transaminase (AST) = 5 × UNL; 8) The patient voluntarily participates and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Histopathological examination confirmed neuroendocrine carcinoma, small cell carcinoma, goblet cell carcinoid, etc; 2) Functional neuroendocrine tumors requiring long-term SSA to control symptoms, such as islet cell tumor, glucagon tumor, Gastrin tumor, VIP tumor, ACTH tumor, carcinoid syndrome, etc; 3) Urinary routine analysis shows that urine protein = 2+or 24-hour urine protein quantification = 1g; 4) Hypertension that cannot be controlled by medication (systolic blood pressure>140mgHg or diastolic blood pressure>90mmHg); 5) Serious gastrointestinal diseases that may affect absorption, including but not limited to peptic ulcer, ulcerative colitis, active gastrointestinal bleeding, gastrointestinal obstruction, severe diarrhea, etc; 6) Within 3 months, there is a history of severe hemorrhagic disease (single bleeding>30ml), or within 1 month, there is a history of hemoptysis (single hemoptysis>5ml), or there have been thromboembolic events (including pulmonary embolism, cerebral infarction, etc.) within 12 months; 7) Received surgical treatment (excluding biopsy) within 4 weeks or the surgical incision has not yet healed; 8) Severe cardiovascular diseases, including but not limited to acute myocardial infarction, unstable angina, heart failure, ventricular arrhythmias requiring medication, and left ventricular ejection fraction<50%; 9) The electrocardiogram indicates a corrected QT interval of = 480ms; 10) History of other malignant tumors with a disease-free survival period of<5 years (except for cured skin basal cell carcinoma, cured cervical in situ carcinoma, and gastrointestinal tumors confirmed to be cured through endoscopic mucosal resection); 11) Existence of immune deficiency diseases or HIV infection; 12) Severe uncontrolled acute infection (infection causing fever above 38 ?); 13) Have a history of active hepatitis B or active hepatitis C, and hepatitis B virus (HBV) DNA titer test = 1 × 104IU/mL, hepatitis C virus (HCV) RNA detection = 1 × 103IU/mL; 14) If other serious internal and external diseases are combined, affecting organ function, and the researcher believes that it is not suitable to participate in this clinical trial; 15) Participated in clinical trials of other new drugs within 4 weeks; 16) Pregnant or lactating women or patients with fertility (male or female with less than 1 year of amenorrhea) are unwilling to take contraceptive measures; 17) Subjects with a history of allergic or hypersensitive reactions to the study drug components; 18) The researchers determined that patients who are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactDan Cao
West China Hospital, Sichuan University
Outcome results
None listed