A Study of Standard Of Care Versus Radio Ablation in Early Stage HCC (SOCRATES HCC)
2026年6月4日 更新者：University Health Network, Toronto
A Randomized Controlled Trial of Standard Of Care Versus Radio Ablation in Early Stage Hepatocellular Carcinoma
This Phase II Prospective, parallel and open-label randomised control trial will investigate whether a radiotherapy technique (called SABR) can treat early stage liver cancer more effectively than current treatments which use heating probes directly inserted into the tumour or chemotherapy or radioactive particles injected into the blood supply of the tumour.
Investigators hypothesize SABR will result in higher rates of freedom from local progression (FFLP) at 2 years compared to percutaneous thermal ablation ± TACE or transarterial therapies (TACE/TARE).The study will also look at other important outcomes such as progression free survival, overall survival, side effects, quality of life and people's experiences of their treatment.
研究概览
详细说明
The SOCRATES randomised controlled trial will assess the efficacy, toxicity, HRQoL profile and cost effectiveness of SABR compared to the current SOC treatment in patients with first diagnosis of unresectable, single nodule HCC.
Participants will be placed into one of two groups based on the size of their tumour and whether thermal ablation is an appropriate treatment for them.
The study will include about 218 participants in total.
Participants will be randomly assigned to receive either SABR or the current standard of care.
Standard care may include thermal ablation, transarterial chemoembolisation (TACE), or transarterial radioembolisation (TARE).
研究类型
介入性
注册 (估计的)
218
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：Michael Yan, MD MPH FRCPC DABR
- 电话号码：(416) 946-2320
- 邮箱：Michael.Yan@uhn.ca
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G 2M9
- 招聘中
- University Health Network - Princess Margaret Cancer Centre
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接触：
- Michael Yan, MD MPH FRCPC DABR
- 邮箱：Michael.Yan@uhn.ca
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Waratah、澳大利亚
- 招聘中
- Trans Tasman Radiation Oncology Group
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接触：
- Alan Wigg
- 邮箱：Alan.wigg@sa.gov.au
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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:
1) Histological or radiological diagnosis of single, new HCC with largest diameter =8 cm (BCLC stage 0 or A).
- a) If prior history of HCC, the prior HCC must have been:
- Early stage, solitary HCC, =5 cm in size and,
- Have arisen within a different liver segment to the current HCC and,
- Treated with curative intent therapy >2 years prior with no evidence of active disease at the site.
- 2) As per local multidisciplinary HCC meeting consensus patient is suitable for percutaneous thermal ablation and/or transarterial therapies and not suitable for or declined liver resection and not planned for liver transplantation.
- 3) Child-Pugh score =B7* with no or diuretic-controlled ascites
- 4) ECOG performance status =2
- 5) Platelets =50x109/L, Haemoglobin =80 g/L, Neutrophils =1.0x109/L, INR <1.8 (except if on therapeutic anticoagulation)
- 6) 18 years of age or older and able to provide written consent
Exclusion Criteria:
- 1) Presence of multifocal HCC, macrovascular invasion or extrahepatic disease
- 2) Prior treatment for any HCC within last 2 years.
- 3) Clinically evident ascites or hepatic encephalopathy
- 4) Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour.
- 5) Untreated Hepatitis B or C
- 6) Known additional invasive malignancy (excluding non-melanoma skin cancer) that is progressing or required treatment within the last 2 years.
- 7) Pregnancy
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：随机化
- 介入模型：并行分配
- 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：放射治疗
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SABR will be delivered in 3 or 5 outpatient treatment sessions (each 20 to 45 minutes in duration) spaced out over 1 to 2 weeks.
The exact number of treatment sessions received, and the duration of each session depends on the size and location of the liver cancer.
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其他：Standard Of Care Treatment
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Patients will receive standard of care treatment (SOC) as per their institution's local practice that will be administered by a doctor called an Interventional Radiologist.
The therapies offered will depend on the size and location of the liver cancer and may include one or a combination of radiofrequency ablation (RFA) / microwave ablation (MWA) and/or transarterial chemoembolization (TACE) / transarterial radioembolisation (TARE).
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Freedom from local progression (FFLP)
大体时间：2 years
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2 years
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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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总生存期（OS）
大体时间：2年
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2年
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无进展生存期 (PFS)
大体时间：2年
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2年
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Safety and adverse events (CTCAE v5.0)
大体时间：2 Years
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2 Years
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Patient reported outcomes (EORTC QLQ-C30)
大体时间：2 Years
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The C30 is a 30-item instrument that evaluates HRQOL comprised of five functional scales (physical, cognitive, emotional, social, and role) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, anorexia, constipation, diarrhea, and financial), and a global QoL scale. Responses are scored on a linear scale from 0 to 100. Higher scores on functioning/global health indicate a better, healthier state. Higher scores on symptom scales indicate a higher symptom burden or worse condition. |
2 Years
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Patient reported outcomes (QLQ-HCC18)
大体时间：2 Years
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QLQ-HCC18 is a questionnaire where patients report symptoms or problems on a scale of 1 (not much) to 4 (very much).
Higher scores on symptom scales indicate a higher symptom burden or worse condition.
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2 Years
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Cost-effectiveness analysis
大体时间：2 Years
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Incremental cost per outcome
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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。
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5月11日
初级完成 (估计的)
2032年4月1日
研究完成 (估计的)
2032年4月1日
研究注册日期
首次提交
2026年5月13日
首先提交符合 QC 标准的
2026年6月4日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年6月5日
上次提交的符合 QC 标准的更新
2026年6月4日
最后验证
2026年6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.
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