An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide, long-acting Octreotide.
- Who it may be relevant to
- Registry conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
Interventions
- Drug Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide. - Drug long-acting Octreotide
High-dose long-acting Octreotide.
Primary outcome measures
- Progression-free survival (PFS) assessed by BICR [Time frame: Up to 1 year follow-up]
Secondary outcome measures (5)
- Overall Survival (OS) [Time frame: Up to 5 years follow-up]
- Objective Response Rate (ORR) [Time frame: up to 1 year follow-up]
- Duration of Overall Response (DoR) [Time frame: Up to 1 year follow-up]
- Disease Control Rate (DCR) [Time frame: Up to 1 year follow-up]
- Incidence and severity of adverse event (AE) and serious adverse event (SAE) [Time frame: Up to 5 years follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Fudan University Shanghai Cancer Center — Shanghai
- Tianjin University Cancer Institute and Hospital — Tianjin
Identifiers
NCT: NCT05884255 · HRFS-Q-2011-301