Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Shenzhen)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Short term efficacy evaluation
研究概览
简要总结
This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device.
The trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.
详细描述
The trial is structured in two distinct phases. Phase 1 - Clinical Trial: This phase spans from the initial screening through to 90 days post-treatment. Its primary objective is to assess the efficacy and safety of PROTEUS® PLUS in accordance with the regulatory requirements set by the National Medical Products Administration (NMPA) for product registration. Phase 2 - Long-Term Follow-Up: Extending up to five years after treatment, this phase aims to monitor the long-term efficacy and safety of PROTEUS® PLUS. Periodic reports will be submitted in compliance with NMPA guidelines.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with benign/malignant intracranial tumor and malignant solid tumor of head and neck, chest, abdomen, spine, pelvic cavity and limbs
- •At least 1 lesion of the tumor to be treated is measurable according to RECIST criteria
- •Expected survival time of more than 6 months
- •ECOG performance status of 0 to 2
- •Negative pregnancy test (HCG) results within 7 days prior to the first treatment for females of childbearing potential
排除标准
- •Contraindications to radiation therapy
- •Presence of other uncontrolled tumors other than the tumor to be treated
- •Implants and devices in the treatment area
- •Re-irradiation
- •Other conditions that are not suitable for inclusion, as judged by the investigator
研究组 & 干预措施
Treatment
Subjects will undergo radiation therapy using the investigational medical device (PROTEUS® PLUS) in accordance with the prescribed treatment plan.
干预措施: Proton Beam Therapy (PBT) (Device)
结局指标
主要结局
Short term efficacy evaluation
时间窗: 90 days after the treatment completion
Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria
Short term safety evaluation
时间窗: 90 days after the treatment completion
Toxicity of grade 3, 4 and 5 according to CTCAE
次要结局
- Additional short term Safety evaluation(90 days after the treatment completion)
- Long term Efficacy evaluation(6 months, 1 year, 2 years and 5 years after the treatment completion)
- Long term Safety evaluation(6 months, 1 year, 2 years, and 5 years after the treatment completion)