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Trial Title:
An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
NCT ID:
NCT05884255
Condition:
Advanced Gastroenteropancreatic Neuroendocrine Tumor
Conditions: Official terms:
Neuroendocrine Tumors
Octreotide
Lutetium Lu 177 dotatate
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
Description:
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting
Octreotide
Arm group label:
Treatment group A
Intervention type:
Drug
Intervention name:
long-acting Octreotide.
Description:
High-dose long-acting Octreotide.
Arm group label:
Treatment group B
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Investigator:
Last name:
Jihui Hao
Email:
Principal Investigator
Start date:
July 6, 2023
Completion date:
October 2030
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05884255
