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Recruiting Phase 3

An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

NCT05884255 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2023-07-06
Last updated
2026-05-19

Condition(s) studied

Advanced Gastroenteropancreatic Neuroendocrine Tumor

Investigational drug(s) / intervention(s)

Lutetium (177Lu) Oxodotreotide Injection;long-acting Octreotidelong-acting Octreotide

Lutetium (177Lu) Oxodotreotide Injection;long-acting Octreotide: Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.

long-acting Octreotide: High-dose long-acting Octreotide.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression-free survival (PFS) assessed by BICR — Up to 1 year follow-up

Trial sites (2)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Tianjin University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05884255 on ClinicalTrials.gov ↗ ← All trials in China