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

NCT05884255

RecruitingPhase 3

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor

Interventions: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide, long-acting Octreotide

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (2)

Shanghai, Shanghai Municipality, China
Tianjin, Tianjin Municipality, China