NCT05884255招募中3 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS) assessed by BICR
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment group B
Active Comparator
干预措施: long-acting Octreotide (Drug)
Treatment group A
Experimental
干预措施: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by BICR
时间窗: up to 1 years follow-up
Progression-free survival (PFS) assessed by BICR
时间窗: Up to 1 year follow-up
次要结局
- Overall Survival(OS)(up to 5 years follow-up)
- Objective Response Rate(ORR)(up to 1 years follow-up)
- Duration of Overall Response(DoR)(up to 1 years follow-up)
- Disease Control Rate(up to 1 years follow-up)
- Incidence and severity of AE and SAE(up to 5 years follow-up)
- Duration of Overall Response (DoR)(Up to 1 year follow-up)
- Disease Control Rate(Up to 1 year follow-up)
- Incidence and severity of AE and SAE(Up to 5 year follow-up)
- Overall Survival (OS)(Up to 5 years follow-up)
- Objective Response Rate (ORR)(up to 1 year follow-up)
- Incidence and severity of adverse event (AE) and serious adverse event (SAE)(Up to 5 years follow-up)
- Disease Control Rate (DCR)(Up to 1 year follow-up)
研究者
研究点 (2)
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