Evaluation of Stereotactic Body Radiotherapy as a Bridge Therapy for Hepatocellular Carcinoma Patients Enlisted for Liver Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of stereotactic body radiotherapy (SBRT) as bridging therapy for patients with hepatocellular carcinoma (HCC) enlisted for liver transplantation (LT).
研究概览
简要总结
The aim of this trial is to carry out the first prospective multicentric study which evaluates the efficacy and the safety of SBRT in HCC patients enlisted for LT and not suitable for other bridging interventional treatments (RF or TACE).
The incidence of hepatocellular carcinoma (HCC) is increasing worldwide and is currently the first indication for Liver transplantation (LT). HCC patients access to LT is not only determined by the underlying liver function but also by the alpha-fetoprotein (aFP) score which allows to better identify patients with high risk of recurrence. LT is the best curative treatment as it can cure both the tumor and the underlying liver disease. However, the access to LT is limited due to organ shortage and preserved liver function for the majority of the patients with HCC. Bridging therapies, such as ablation by radiofrequency (RF) or microwaves, or trans-arterial chemoembolization (TACE), are carried out routinely to prevent the risk of tumor progression and drop-out during the waiting time (the drop-out rate being 20%). Nevertheless, only 50 to 70% of patients in France will have access to these treatments due to specific contraindications.
Stereotactic body radiotherapy (SBRT) has emerged as a non-invasive alternative and potentially efficient treatment of single or bilocular HCC. SBRT is a high-precision technique allowing to deliver a precise high dose irradiation on moving intrahepatic lesions. RTS is feasible only when the hepatic reserve is sufficient to avoid radic hepatitis.
Advantages of SBRT, as compared to TACE or RF, are 1) to preserve the hepatic artery, which can be altered by TACE 2) to allow access to complex tumors locations or superficial lesions not feasible by RF 3) to avoid any tumor spread related to punctures 4) to avoid general anesthesia.
However, SBRT has not been validated as bridging therapy before LT in a prospective study. Thus, this study is the first prospective multicentric study to evaluate this treatment modality in HCC patients enlisted for LT not suitable to RF or TACE.
详细描述
Hypothesis for the study:
The hypothesis is that SBRT in HCC patients enlisted for LT and not suitable to liver resection, RF, or TACE, is a safe and effective option to bring those patients to LT while limiting HCC progression during waiting time.
This study is the first prospective multicentric study to evaluate this treatment modality in this population.
Overview of the multimodal management of hepatocellular carcinoma Liver cancer is the fourth cause of cancer-related death (GLOBOCAN), with an increasing incidence over the last decades.
The best curative treatment for HCC remains liver transplantation (LT) as it can cure both the tumor and the underlying liver disease. 5-year survival rates reach 60-70% in patients with HCC after LT. However, the number of patients waiting for LT is by far exceeding the number of available donors: in 2017, there were 2.4 candidates for one graft (ABM, Rapport annuel). The global organ shortage and the risk of HCC recurrence after LT have therefore been taken into account in the therapeutic algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Patients enlisted for LT in France for HCC or undergoing pre-transplant assessment (under Agence de Biomédecine (ABM) regulation)
- •HCC previously treated or naive
- •Suitable for stereotactic radiotherapy:
- •ECOG, performance status score ≤ 2,
- •Child-Pugh Score ≤ B7,
- •Number of lesions between 1 and 3
- •Maximum tumor size < 5cm Liver remnant volume ≥ 700 ml. The liver remnant volume will be measured at the baseline visit or M
- •If the volume is <700 ml, the patient will be in early discontinuation of the study.
- •Health insurance coverage.
- •Written informed consent
排除标准
- •Inability to comply with study procedures
- •Patients under guardianship or curatorship
- •Pregnancy (Positiveurinary/blood βHCG test)
研究组 & 干预措施
Patients with hepatocellular carcinoma enlisted for a liver transplant and eligible for SBRT
All patients enrolled in the trial and responding to inclusion/exclusion criteria will receive SBRT (a high-precision technique allowing to deliver a precise high dose irradiation on moving intrahepatic lesions).
干预措施: Stereotactic Body Radiotherapy (SBRT) (Radiation)
结局指标
主要结局
To evaluate the efficacy of stereotactic body radiotherapy (SBRT) as bridging therapy for patients with hepatocellular carcinoma (HCC) enlisted for liver transplantation (LT).
时间窗: Within 15 months following SBRT.
Bridge therapy success is defined as follows: * Patient with liver transplantation within 15 months after the first session SBRT or, * Patient still enlisted (ie with aFP score\<2) at M15 from the first session SBRT. All other cases will be considered as failure.
次要结局
- To estimate the overall and disease-free survival after LT for HCC treated with SBRT on waiting list(Up to 24 months post LT)
- To assess the occurrence of adverse events related to SBRT during waiting time period and after LT(Before and after LT (maximum 39 months after inclusion and within 24 months post LT))
- To evaluate the pathological response after SBRT on the liver explant after LT(After LT surgery (maximum 39 months after inclusion and within 24 months post LT).)
- To assess the performance of liver imaging (using RECIST 1.1, mRECIST) to predict the pathological response(Preceding LT surgery (and within 15 months after inclusion at maximum))