Neuroendocrine tumor
Conditions
Interventions
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria to enter the study: 1. Patients voluntarily join the study and sign informed consent; 2. Age =18 years old, male or female; 3. Locally advanced or metastatic NET that cannot be resected (or refuses to be resected); 4. According to the WHO 2019 classification, G1 or G2 gastrointestinal and pancreatic neuroendocrine tumors (GEP-NET); Well-differentiated lung NET (typical carcinoid or atypical carcinoid); Well-differentiated other tissues NET (such as ovary, kidney, etc.) or from unknown tissues can also be included. 5. 68Ga/18F-SSA PET/CT, 99mTc-SSA SPECT imaging or immunohistochemistry showed positive somatostatin receptor (SSTR); 6. Presence of at least one measurable lesion (RECIST v1.1); 7. ECOG PS: 0 or 1; 8. Fertile women: must agree to use a reliable method of contraception from the time of signing the informed consent until 6 months after the last dosing of the study drug. The HCG test must be negative within 7 days before the start of study treatment; And must be non-lactation period; 9. For male patients whose partner is a fertile woman, consent must be given to the use of a reliable method of contraception from the signing of the informed consent until 6 months after the last administration of the investigatory drug. Male patients must also agree not to donate sperm within the same time frame.
Exclusion criteria
Exclusion criteria: Participants will not be admitted to the study if they have had any of the following: 1. Malignancies other than GEP-NET within 5 years or at the same time. Cured tumors such as carcinoma in situ of the cervix, non-melanin skin cancer, superficial bladder cancer (Ta, Tis, and T1) could be included. 2. Previous systemic treatment with somatostatin analogues (SSA), interferon, chemotherapy or targeted therapy; 3. Radiotherapy, local ablation, transcatheter arterial embolization (TAE), transcatheter arterial chemoembolization (TACE), or major NET-related surgery within 12 weeks prior to receiving the investigational drug; 4. The subject has participated in another clinical study and received treatment within one month prior to the first use of the investigational drug; 5. Known allergy to the investigational drug or excipient; 6. According to the judgment of the researcher, the patient has other factors that may affect the study results or force the study to be terminated, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious abnormalities in laboratory examination, and family or social factors, which will affect the safety of the patient; 7. Subjects are pregnant or lactating; 8. Other factors deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-week Clinical Benefit Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;Disease control rate;Progression free survival;Time to Progression; | — |
Countries
China
Contacts
Public ContactJie Chen
Fudan University Shanghai Cancer Center
Outcome results
None listed