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

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor

Treatments: Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide; Drug: long-acting Octreotide.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05884255

HRFS-Q-2011-301

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Treatment group A

Experimental group

Treatment:

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

Treatment group B

Active Comparator group

Treatment:

Drug: long-acting Octreotide.