SIB Accelerated Hyperfractionated RT for High-Proliferation NSCLC (HP-SIB-AHFRT)
A Single-arm Phase I/II Clinical Study of Simultaneous Integrated Boost Accelerated Hyperfractionated Radiotherapy for High-proliferation Non-small Cell Lung Cancer
This is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung cancer (NSCLC).
研究概览
研究类型
介入性
注册 (估计的)
15
阶段
- 不适用
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：Lu Wang
- 电话号码：+86 057137826869
- 邮箱：dluwang0727@163.com
学习地点
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- 招聘中
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University
-
-
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:
- Age ≥ 18 years, male or female;
- Histologically or cytologically confirmed high-proliferation non-small cell lung cancer (NSCLC);
- Assessed by a multidisciplinary team (MDT) and planned to receive thoracic radiotherapy (either curative or palliative), regardless of stage.
Exclusion Criteria:
- Small cell histology;
- Severe cardiac disease (New York Heart Association [NYHA] functional class ≥ III, uncontrolled arrhythmia, or myocardial infarction within the past 6 months);
- Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use effective contraceptive measures;
- Concurrent participation in other interventional clinical trials;
- Other conditions deemed by the investigator to make the patient unsuitable for enrollment (e.g., severe mental illness).
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 |
|---|---|
|
实验性的：hyperfractionated radiotherapy
simultaneous integrated boost accelerated hyperfractionated radiotherapy
|
simultaneous integrated boost accelerated hyperfractionated radiotherapy
|
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 |
|---|---|---|
|
Incidence of Acute Treatment-Related Toxicity
大体时间：From the start of radiotherapy through 90 days after completion of radiotherapy.
|
The incidence and severity of acute treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
|
From the start of radiotherapy through 90 days after completion of radiotherapy.
|
|
Incidence of Late Treatment-Related Toxicity
大体时间：From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy.
|
The incidence and severity of late treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
|
From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Response Rate (ORR)
大体时间：Every 3 months after completion of radiotherapy, up to 2 years.
|
Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
|
Every 3 months after completion of radiotherapy, up to 2 years.
|
|
Progression-Free Survival (PFS)
大体时间：From enrollment until documented disease progression or death from any cause, up to 2 years.
|
Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first.
Disease progression will be assessed according to RECIST version 1.1.
|
From enrollment until documented disease progression or death from any cause, up to 2 years.
|
|
Overall Survival (OS)
大体时间：From enrollment until death from any cause, up to 2 years.
|
Overall survival is defined as the time from enrollment to death from any cause.
|
From enrollment until death from any cause, up to 2 years.
|
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。
调查人员
- 首席研究员：Ting Zhang、2nd Affiliated Hospital, School of Medicine, Zhejiang University
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)
2026年6月16日
初级完成 (估计的)
2028年6月16日
研究完成 (估计的)
2028年6月16日
研究注册日期
首次提交
2026年8月4日
首先提交符合 QC 标准的
2026年9月13日
首次发布 (实际的)
2026年9月16日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月13日
最后验证
2026年7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.