NET
Conditions
Interventions
group 1:surufatinib
Sponsors
Shanghai General Hospital
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; 2. Age >=18, male or female; 3. Neuroendocrine tumors confirmed by histopathology or cytology (patients with neuroendocrine tumors with G1, G2, G3 stages diagnosed according to WHO2019 standards); 4. At least 1 measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST V1.1); 5. It has been more than 7 days since the end of the last systematic treatment, and it has been more than 4 weeks since the end of the palliative therapy of the limited parts is allowed; 6. Expected survival >=12 weeks; 7. Researchers assess benefits; 8. Adequate organ and bone marrow function; 9. Fertile male or female patients volunteered to use effective contraceptive methods, such as double-screen contraceptive methods, condoms, oral or injectable contraceptive drugs, intrauterine devices, etc. during the study period and 6 months after the last study drug. All female patients will be considered fertile unless the woman has undergone natural menopause, artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or radiation of the ovaries, etc.). Otherwise, the serum of the female patient was not pregnant 7 days before the study, and the patient must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of other malignant tumors within the past 5 years, except for effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or effectively resected in-situ cervical cancer and breast cancer; 2. Receiving other investigational drugs or approved or under development antitumor therapies; 3. Patients with contraindications of surufatinib (such as: active bleeding, ulcer, intestinal perforation, intestinal obstruction, hypertension that cannot be controlled by drugs, grade III-IV cardiac insufficiency, 30 days after major surgery, severe liver and kidney insufficiency, etc.); 4. The patient has any current disease or condition that affects absorption of the drug, or the patient is unable to take surufatinib orally; 5. Demonstrated allergy to any component of the test drug and/or its excipients; 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 clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to suspect the patient has not closed state of an illness or using the study drug (such as need to have a seizure and treatment), or will affect the interpretation of results, Or a situation that puts the patient at high risk; 9. For the first study, take drugs containing hypericum perforatum within 3 weeks before medication, or take other CYP3A4 strong inducer or inhibitory agents within 2 weeks before medication; 10. Judging by the researchers, there are other participants may result in this study were forced to midway termination or don't fit into the factors, such as, and other serious diseases (such as serious urine sugar disease, thyroid disease, spinal cord compression, superior vena cava syndrome, mental illness), there are serious abnormal laboratory examination, accompanied by factors such as family or society, Will affect the safety of the subject, or the collection of data and samples).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;objective response rate;overall survival;disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| security; | — |
Countries
China
Contacts
Public ContactLong Jiang
Shanghai General Hospital
Outcome results
None listed