NCT05884255RecruitingPhase 3
An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
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.
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 22 May 2023
- Start date
- 6 Jul 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT05884255
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 220
- From 6 Jul 2023 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- There are clinical symptoms or diseases of the heart that are not well controlled;
Lab values
- Diabetes (fasting blood glucose \> 2 × ULN) that cannot be well controlled after optimal medical support treatment;
Other
- Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Tianjin University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.