An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
NCT ID: NCT05884255
Last Updated: 2023-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2023-07-06
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group A
Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide
Treatment group B
long-acting Octreotide.
High-dose long-acting Octreotide.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tianjin University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Other Identifiers
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HRFS-Q-2011-301
Identifier Type: -
Identifier Source: org_study_id
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