Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- rate of successive tumour downstaging
概览
简要总结
Hepatocellular carcinoma (HCC) is one of the commonest cancers worldwide and ranks the third on the incidence of cancer-related death. There are more than 500000 new cases diagnosed annually worldwide. The incidence and prevalence of HCC are on rising trend with the majority of the disease burden is in Asia where viral hepatitis B is endemic. Surgical resection, radiofrequency ablation (RFA) and liver transplantation (LT) represent the only chance of cure for HCC patients. Despite more aggressive surgical approach has been adopted in most Asian countries, yet curative intervention remains only amendable in 30% of patients. Most patients are diagnosed with intermediate or advanced stage diseases; the long-term cure rate is only 0-10%. Hence, every effort has been made in an attempt to convert inoperable HCC into operable disease (i.e. downstaging) in order to improve the chance of survival of these patients. The current study, to our knowledge, will be the first study in the field to deploy a novel treatment strategy to deploy both immunotherapy and stereotactic beamed radiotherapy to induce tumor shrinkage rendering it become operable cancer.
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
- •Diagnosis of HCC is made according to American Association for the Study of Liver Diseases (AASLD) practice guideline 2010: patients with cirrhosis of any etiology and patients with chronic hepatitis B (HBV) who may not have fully developed cirrhosis, the presence of liver nodule \>1cm and demonstrated in a single contrast enhanced dynamic imaging \[either computed tomography (CT) or magnetic resonance imaging (MRI)\] of intense arterial uptake and "washout" in portal venous and delayed phases.
- •Tumor size 5-25 cm or number of lesions ≤3 or segmental portal vein involvement
- •Age: 18-80 years old
- •Child Pugh liver function class A-B7
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
排除标准
- •Prior invasive malignancy
- •Prior radiotherapy to the region of liver or selective internal radiotherapy
- •Severe, active co-morbidity
- •Presence of extra-hepatic metastases (M1)
- •Main portal vein or inferior vena cava (IVC) thrombosis or involvement
- •Presence of ascites or encephalopathy
- •Contraindicated of SBRT:
- •Any one hepatocellular carcinoma \> 15 cm
- •Total maximal sum of hepatocellular carcinoma \> 25 cm
- •More than 3 discrete hepatic nodule
结局指标
主要结局
rate of successive tumour downstaging
时间窗: at the time point of receiving surgery
show how many patients will be downstaged by receiving surgery
次要结局
未报告次要终点
研究者
Albert Chi Yan Chan
Clinical Professor
The University of Hong Kong