Treatment for advanced gastrointestinal pancreatic neuroendocrine tumors using Lutetium (177Lu) Oxodotreotide Injection
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.
This study is testing if a new injection can help people with advanced pancreatic neuroendocrine tumors feel better and live longer when combined with another medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05884255 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Lutetium (177Lu) Oxodotreotide Injection in patients with advanced gastrointestinal pancreatic neuroendocrine tumors. It is an open-label Phase 3 study that includes patients aged 18 to 75 with unresectable locally advanced or metastatic tumors of low and medium grade. Participants will receive the injection along with long-acting Octreotide as part of the treatment regimen. The study aims to determine how well this treatment works compared to existing options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors confirmed by histopathology.
Not a fit: Patients with central nervous system metastasis, uncontrolled heart disease, or severe urinary dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastrointestinal pancreatic neuroendocrine tumors.
How similar studies have performed: Other studies have shown promise with similar treatments for neuroendocrine tumors, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xueying Zheng
- Email: xueying.zheng.xz17@hengrui.com
- Phone: +0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.