Clinical trial · Interventional
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.
NCT05884255CI-TRIAL-00111943recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastroenteropancreatic Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| long-acting Octreotide | Drug | — | UNRESOLVED |
| Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group A
- interventionNames
- Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
- type
- ACTIVE_COMPARATOR
- label
- Treatment group B
- interventionNames
- Drug: long-acting Octreotide
Primary outcomes (1)
- measure
- Progression-free survival (PFS) assessed by BICR
- timeFrame
- Up to 1 year follow-up
Secondary outcomes (5)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.