RecruitingPhase 3

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

China220 participantsStarted 2023-07-06

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

Progression-free survival (PFS) assessed by BICR

Timeframe: Up to 1 year follow-up

Trial details

NCT IDNCT05884255

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Xueying Zheng

+0518-82342973 xueying.zheng.xz17@hengrui.com

View on ClinicalTrials.gov More Advanced Gastroenteropancreatic Neuroendocrine Tumor trials