Neuroendocrine Neoplasms
Conditions
Interventions
Experimental group:Surufatinib monotherapy/combination therapy
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fully understand this study and voluntarily sign the informed consent form; 2. Age >=18 years, both male and female eligible; 3. Patients with advanced neuroendocrine tumors confirmed by pathological histology or cytology; 4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1); 5. At least 7 days since the last systemic therapy, prior palliative radiotherapy to localized areas is allowed if completed more than 4 weeks ago; 6. Expected survival >=12 weeks; 7. Assessed by the investigator to potentially benefit; 8. Sufficient organ and bone marrow function; 9. Women of childbearing potential must have a negative serum pregnancy test within 14 days before treatment and agree to use medically approved effective contraception during the study and for 3 months after the last dose of the study drug (e.g., intrauterine device, contraceptive devices, or condoms). For male subjects with partners of childbearing potential, surgical sterilization is required, or it is recommended to use effective contraception during the study and for 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant tumors in the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of the skin that has been effectively treated, or carcinoma in situ of the cervix or breast cancer that has been effectively resected; 2. Concurrently receiving other experimental drugs or approved or investigational anti-tumor treatments; 3. Patients with contraindications to sorafenib (e.g., active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrolled hypertension due to medication, class III-IV heart failure, within 30 days after major surgery, severe hepatic or renal insufficiency, etc.); 4. Patients currently have any disease or condition affecting drug absorption, or patients who cannot take sorafenib orally; 5. Known allergy to the investigational drug or any components in its formulation; 6. Pregnant (positive pregnancy test before medication) or breastfeeding women; 7. Patients with large pleural effusion or ascites requiring drainage; 8. Any other disease with clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities, which, according to the investigator's judgment, are reasonably suspected to render the patient unsuitable for the investigational drug (e.g., seizure disorders requiring treatment), or may affect the interpretation of study results, or put the patient at high risk; 9. Use of drugs containing Forsythia suspense components within 3 weeks prior to the first dose of investigational drug, or use of other strong CYP3A4 inducers or inhibitors within 2 weeks prior; 10. According to the investigator's judgment, there are other factors that may cause the study to be prematurely terminated or make the subject unsuitable for inclusion, such as other serious comorbidities (e.g., severe diabetes, thyroid disease, spinal cord compression, superior vena cava syndrome, psychiatric disorders), severe laboratory test abnormalities, or family or social factors that may affect the safety of the subject or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) ;Disease Control Rate (DCR) ;Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactLiang Liu
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed