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

Study Overview
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Brief Summary
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The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in Subjects With advanced gastrointestinal pancreatic neuroendocrine tumors.

Official Title
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Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

Conditions
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Advanced Gastroenteropancreatic Neuroendocrine Tumor

Intervention / Treatment
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* Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
* Drug: long-acting Octreotide.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide<br>* Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide<br>|
| Active Comparator: Treatment group B<br> | Drug: long-acting Octreotide.<br>* High-dose long-acting Octreotide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) assessed by BICR |  | up to 1 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) |  | up to 5 years follow-up | 
| Objective Response Rate(ORR) |  | up to 1 years follow-up | 
| Duration of Overall Response(DoR) |  | up to 1 years follow-up | 
| Disease Control Rate |  | up to 1 years follow-up | 
| Incidence and severity of AE and SAE |  | up to 5 years follow-up |