An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
Recruiting · NCT05884255 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotidelong-acting Octreotide
What this trial is about
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Able and willing to provide a written informed consent;
- 18\~75 years old,male or female;
- ECOG performance status 0 or 1;
- Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology.
Exclusion criteria
- 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;
- There are clinical symptoms or diseases of the heart that are not well controlled;
- Diabetes (fasting blood glucose \> 2 × ULN) that cannot be well controlled after optimal medical support treatment;
- Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.
Where it is running
2 locations listed.
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China
- Tianjin University Cancer Institute and Hospital - Tianjin, Tianjin Municipality, China