DRUG
Lutetium (177Lu) Oxodotreotide Injection;long-acting Octreotide
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.
Status
Recruiting
Phase
Phase 3
Enrollment
220
Locations
2
Results
Not posted
Publications
0
Study summary
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
Interventions
DRUG
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.
DRUG
High-dose long-acting Octreotide.
Timeline
First posted
Jun 1, 2023
Study start
Jul 6, 2023
Primary completion
Dec 2026
Study completion
Oct 2030
Results posted
Not reported
Registry updated
May 19, 2026
Outcomes
Progression-free survival (PFS) assessed by BICR
Time frame · Up to 1 year follow-up
Overall Survival (OS)
Time frame · Up to 5 years follow-up
Objective Response Rate (ORR)
Time frame · up to 1 year follow-up
Duration of Overall Response (DoR)
Time frame · Up to 1 year follow-up
Disease Control Rate (DCR)
Time frame · Up to 1 year follow-up
Incidence and severity of adverse event (AE) and serious adverse event (SAE)
Time frame · Up to 5 years follow-up
Eligibility
Inclusion Criteria: 1. Able and willing to provide a written informed consent; 2. 18\~75 years old,male or female; 3. ECOG performance status 0 or 1; 4. Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology. Exclusion Criteria: 1. Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks; 2. There are clinical symptoms or diseases of the heart that are not well controlled; 3. Diabetes (fasting blood glucose \> 2 × ULN) that cannot be well controlled after optimal medical support treatment; 4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
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