Clinical Research Directory

TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS

The goal of this Phase III randomized controlled, open-label clinical trial is to evaluate the efficacy and safety of adding peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE to standard-of-care chemotherapy (CAPTEM), compared with CAPTEM alone, in adults with unresectable or metastatic, WHO Grade 3 well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with a Ki-67 index of \>20% to \<55% and positive somatostatin receptor imaging. The main questions it aims to answer are: * Whether the addition of PRRT to CAPTEM improves 1-year progression-free survival (PFS) compared with CAPTEM alone. * Whether the addition of PRRT to CAPTEM results in differences in \*\*disease control rate, overall survival, treatment-related toxicity, and quality of life\*\* compared with CAPTEM alone. Researchers will compare Arm A (CAPTEM alone) with Arm B (PRRT plus CAPTEM) to evaluate differences in progression-free survival, disease control, overall survival, toxicity, and quality of life between the two treatment groups. Participants will be randomly assigned in a 1:1 ratio to either treatment arm. Participants will: * Undergo screening and baseline assessments, including physical examination, blood investigations, cardiac assessment, and imaging with Ga-68 DOTA PET/CT and FDG PET/CT. * Receive CAPTEM (capecitabine and temozolomide) as oral chemotherapy according to the study protocol. * If assigned to Arm B, receive four sessions of Lutetium-177 DOTATATE PRRT, at intervals of approximately 6-8 weeks, in addition to CAPTEM. * Undergo regular clinical assessments, laboratory investigations, imaging assessments, and monitoring for adverse events and treatment-related toxicity. * Complete EORTC QLQ-C30 and QLQ-GINET21 questionnaires to assess quality of life. * Continue follow-up after treatment, including clinical and imaging assessments, until disease progression or death.

Incremental Value of Delayed 68Ga-DOTATATE PET/MR in the Detection of Liver Metastases

68-Ga-DOTATATE is a radiotracer targeting somatostatin receptors (SSTR). In this study, we investigated the diagnostic efficacy of delayed \^68\^Ga-DOTATATE PET/MR in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and liver metastases, and performed a head-to-head comparison with conventional 68-Ga-DOTATATE PET/CT.

Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors

There is limited evidence regarding the benefit of adding somatostatin analogs to molecular targeted agents for well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with poor prognostic factors. This trial is conducted to evaluate sirolimus for injection (albumin bound) combined with octreotide long-acting injection in patients with unresectable or recurrent GEP-NETs.

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs

This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to \<18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.