NCT05884255 An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
| NCT ID | NCT05884255 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Advanced Gastroenteropancreatic Neuroendocrine Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-07-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 220 participants in total. It began in 2023-07-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05884255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Gastroenteropancreatic Neuroendocrine Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05884255 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 220 participants.
Is NCT05884255 currently recruiting?
Yes, NCT05884255 is actively recruiting participants. Contact the research team at xueying.zheng.xz17@hengrui.com for enrollment information.
Where is the NCT05884255 trial being conducted?
This trial is being conducted at Shanghai, China, Tianjin, China.
Who is sponsoring the NCT05884255 clinical trial?
NCT05884255 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 220 participants.