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)
Facility
City
Region
Status
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
Tianjin University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Recruiting
More Jiangsu HengRui Medicine Co., Ltd. trials in China
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.
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