The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a Specialized Prostate-specific Membrane Antigen (PSMA) Labeled with Lutetium177, in Patients with Recurrent And/or Metastatic Adenoid Cystic Carcinoma Originating from the Salivary Glands - an Open, Non-commercial Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Assessment of the effectiveness of the study treatment
研究概览
简要总结
Non-commercial phase 2 clinical trial to evaluate the effectiveness, safety and tolerability of treatment using prostate-specific membrane antigen (PSMA) labeled with 177Lutetium in patients with recurrence and/or metastases in adenoid cystic carcinoma originating from the salivary glands of the head and neck region.
Patients with PSMA receptor expression confirmed by PET/CT after administration of 68Ga-PSMA I&T will be eligible for treatment.
详细描述
It is planned to enroll 32 patients diagnosed with non-resectable recurrence and/or dissemination in the course of ACC, whose general condition and life expectancy justify qualification for diagnosis using PSMA 68Ga and treatment with lutetium (177Lu) vipivotide-tetraxetan
The Study assumes the administration of 6 cycles of treatment (lutetium [177Lu] vipivotide-tetraxetan) at 6-week intervals.
If toxicity occurs, the activity of the next dose of the preparation will be modified or its next administration will be delayed by a maximum of 4 weeks.
After completing 6 cycles of therapy, the participant enters the observation phase, which will last until recurrence of the disease is diagnosed or for 2 years after the end of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental
Treatment will consist of administration of 6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks.
干预措施: Lutetium (177Lu) vipivotide tetraxetan (Drug)
结局指标
主要结局
Assessment of the effectiveness of the study treatment
时间窗: 2 years after the end of treatment
Objective response rate (ORR) - RECIST 1.1 score in CT examination 2 years after completion of treatment
次要结局
- Assessment of quality of life(Time from the the date of initiation of treatment to the disease progression or death)
- Assessment of safety and tolerance(Time from the date of initiation of the treatment to disease progression or death)
- Assessment of the effectiveness of the study treatment(Time from the date of initiation of the treatment to the disease progression or death)