Gastroenteropancreatic neuroendocrine tumors
Conditions
Interventions
Experimental group:Injection of 161Tb-DOTATATE
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Fully understood this study and voluntarily signed the informed consent form. 2. Age 18–85 years. 3. ECOG performance status: 0–1. 4. Histopathologically confirmed locally advanced or metastatic neuroendocrine tumor not amenable to surgical resection, with prior receipt of = normal liver uptake). 6. Disease progression prior to randomization, and no new systemic anti-tumor therapy after progression. 7. Adequate major organ function meeting the following key criteria: (1) ALT and AST =3.5×10^9/L, PLT >=100×10^9/L, Hb >=90 g/L. Note: Other routine laboratory values within normal limits or considered acceptable by the investigator.
Exclusion criteria
Exclusion criteria: 1. Not recovered from major trauma (including surgery) within 4 weeks prior to study treatment. 2. Presence of systemic or local severe infection or other serious concurrent diseases. 3. Immunocompromised status or recent use of immunosuppressants or immunostimulants (including various vaccines, etc.). 4. Presence of autoimmune diseases, including rheumatoid arthritis, etc. 5. Poorly controlled arrhythmias, including atrial fibrillation. 6. Cardiac insufficiency exceeding New York Heart Association (NYHA) class II criteria. 7. Hypertension not effectively controlled by medication or other therapeutic measures. 8. History of allergy to any component of the imaging agent including antibodies, or allergic diathesis. 9. Syphilis or HIV positive. 10. Fertile subjects who cannot implement effective contraception. 11. Psychiatric disorders or relevant medical history. 12. Cannot complete PET/CT or SPECT/CT scanning. 13. Unable to collect 30-minute urine sample. 14. Other subjects judged by investigators to be ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy;Blood routine, liver function, kidney function, tumor markers; | — |
Countries
China
Contacts
Public ContactLiming Xiao
Mianyang Central Hospital
Outcome results
None listed