This is a phase I study to assess the safety and efficacy of \[225Ac\]Ac-DOTATATE in patients with inoperable, locally advanced or metastatic, progressive, Well-Differentiatedwell differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine neoplasms with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT).
Patients must have the ability to understand and sign an approved informed consent form (ICF).
Patients must be >= 18 and <＝80 years of age.
Histopathologically confirmed G1 or G2 or G3 GEP-NET or GEP-NEC；
Unresectable locally advanced or metastatic GEP-NET which confirmed by imaging examination.
Pregnant or lactating females.
Received the following treatments within 4 weeks prior to initiation of study treatment, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation.
Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.
Rapid progression with previous PRRT therapy.
Peking University Cancer Hospital & Institute
Lead sponsor
Sinotau Pharmaceutical Group
Collaborator