Overview

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

Status:
Not yet recruiting

Trial end date:
2030-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Jiangsu HengRui Medicine Co., Ltd.

Treatments:

Lutetium Lu 177 dotatate
Octreotide

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