Spatially Fractionated Radiotherapy for Tumor Treatment
2026年8月17日 更新者：Xu Zhi-yuan
Spatially Fractionated Radiotherapy for Bulky or Refractory Solid Tumors: Efficacy and Toxicity
To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors.
研究概览
详细说明
Spatially fractionated radiotherapy (SFRT) is a next-generation technology for precision cancer treatment.
It delivers a highly inhomogeneous dose distribution in three-dimensional space, demonstrating high clinical response rates and minimal toxicity in bulky primary or metastatic malignancies.
Conventional radiotherapy, which uniformly irradiates the entire tumor volume, often causes radiation damage to normal tissues, thereby limiting clinical efficacy.
In contrast, spatially fractionated radiotherapy divides the treatment volume into sub-volumes, alternating high-dose and low-dose regions among these sub-volumes.
Lattice radiotherapy is an advanced technique that integrates the technological advantages of radiosurgery and grid radiotherapy, achieving both biological and physical precision, and represents a novel radiotherapy approach for managing bulky and refractory tumors.
研究类型
介入性
注册 (估计的)
126
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhiyuan Xu, MD
- 电话号码：+86 0755-86913333
- 邮箱：xuzy@hku-szh.org
学习地点
-
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Guangdong
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Shenzhen、Guangdong、中国、518053
- 招聘中
- The University of Hong Kong - Shenzhen Hospital
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接触：
- Zhiyuan Xu, MD
- 电话号码：18307555170
- 邮箱：xuzy@hku-szh.org
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接触：
- Yang Li, MD
- 电话号码：+86 0755-86913333
- 邮箱：yangl1@hku-szh.org
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首席研究员：
- Zhiyuan Xu, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients with a bulky solid tumor with a maximum diameter >4 cm or a refractory solid tumor.
Exclusion Criteria:
- Tumors involving hollow viscera that are considered to have a clinically significant risk of bleeding or perforation.
- Patients with impaired consciousness or who are unable to care for themselves.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：SFRT arm
Adding spatially fractionated radiotherapy (SFRT) to standard-of-care treatment.
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spatially fractionated radiotherapy
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0
大体时间：From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy
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Safety will be assessed by the incidence of treatment-related adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
The number and percentage of participants experiencing at least one treatment-related grade ≥3 adverse event during the specified assessment period will be reported.
Treatment-related serious adverse events and grade 5 adverse events will also be summarized descriptively.Whether this study can be successfully executed and implemented.
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From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy
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Percentage of participants who successfully complete the planned spatially fractionated radiation therapy without treatment discontinuation due to treatment-related toxicity or technical inability to deliver the planned treatment
大体时间：From initiation through completion of the planned spatially fractionated radiation therapy
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Feasibility will be assessed by the proportion of enrolled participants who successfully complete the protocol-specified spatially fractionated radiation therapy (SFRT).
Successful completion is defined as delivery of the planned SFRT according to the protocol without premature discontinuation due to treatment-related toxicity or technical inability to deliver the planned treatment.
The number and percentage of participants meeting this definition will be reported.
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From initiation through completion of the planned spatially fractionated radiation therapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective response rate (ORR) as assessed by RECIST version 1.1
大体时间：From initiation of spatially fractionated radiation therapy until documented disease progression, initiation of subsequent anticancer therapy, death, or the end of follow-up, up to 2 years
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Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) in the irradiated target lesion(s), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
The number and percentage of participants achieving CR or PR will be reported.
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From initiation of spatially fractionated radiation therapy until documented disease progression, initiation of subsequent anticancer therapy, death, or the end of follow-up, up to 2 years
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Local progression-free survival (LPFS) as assessed by RECIST version 1.1
大体时间：From initiation of spatially fractionated radiation therapy until local disease progression or death from any cause, up to 2 years
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Local progression-free survival (LPFS) is defined as the time from initiation of spatially fractionated radiation therapy to the first documented local progression of the irradiated target lesion(s), as assessed according to RECIST version 1.1, or death from any cause, whichever occurs first.
Participants who are alive without documented local progression at the time of analysis will be censored at the date of their last evaluable tumor assessment.
LPFS will be estimated using the Kaplan-Meier method.
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From initiation of spatially fractionated radiation therapy until local disease progression or death from any cause, up to 2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年12月19日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年7月11日
首先提交符合 QC 标准的
2026年8月17日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月17日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.