The DRAGON PLC Trial - An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) With PVE Alone in Primary Liver Cancers.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 358
- 试验地点
- 72
- 主要终点
- Overall survival
研究概览
简要总结
The goal of the DRAGON PLC clinical trial is to determine whether portal vein embolization (PVE) combined with hepatic vein embolization (HVE) improves resectability and overall survival in patients with initially unresectable primary liver cancer compared to standard PVE alone. This trial specifically focuses on patients with hepatocellular carcinoma and cholangiocarcinoma.
The main questions this trial aims to answer are whether combined PVE and HVE increases the proportion of patients who become resectable within 3 weeks and improves 5-year overall survival compared to PVE alone by enhancing liver hypertrophy.
Participants will:
- Undergo either standard PVE or combined PVE and HVE.
- Have regular imaging to assess liver resectability.
- Be monitored for survival outcomes up to 5 years after intervention.
详细描述
Primary liver cancer (PLC) is the third most common cause of cancer death worldwide. Surgical resection is the mainstay for a curative approach as contemporary chemotherapy and immune-based therapies only lead to a median survival of 10-14 months. A complete surgical resection increases the median survival to 42 months (range 32-52 months). However, PLC is mainly diagnosed at an advanced stage and >70% of PLC patients are ineligible for an immediate surgical approach. There are different reasons that make a patient ineligible for surgery, one important reason is the risk of liver failure after the surgery due to a small remnant liver.
This study aims to improve the oncological, radiological and surgical strategy to allow more patients to undergo liver resection safely, to improve quality of life and to extend overall survival at acceptable costs.
Adequate function of the future liver remnant (FLR) is a prerequisite for surgical resectability. This is necessary in order to avoid liver failure after surgery, a major cause of morbidity (38%) and mortality (27%). To mitigate this risk, regenerative strategies based on preoperative calculation of the FLR volume and function are essential. Patients with technically resectable disease but predicted insufficient FLR volume or function are referred to as primarily unresectable or potentially resectable (PU/PR). These patients can undergo strategies that capitalize on the regenerative capacity of the liver which aim to preoperatively increase the FLR volume and function in order to allow surgery. Many of the patients that are primarily unresectable due to an insufficient FLR can become ultimately and safely resectable after the induction of adequate FLR-hypertrophy by the current standard, portal vein embolisation (PVE). However, 25% of patients do not show sufficient FLR growth after PVE and are unable to safely undergo resection. A new approach has been developed to improve this. Combined portal and hepatic vein embolisation (PVE/HVE) has great promise in terms of increasing FLR growth, resection rate (RR), safety and potentially, overall survival. Establishing PVE/HVE as the new standard could result in increased survival and a better quality of life (QoL) for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •PLC diagnosis, specifically iCCC, pCCC, and HCC;
- •Requiring PVE due to an FLR volume is <30% in normally functioning livers, <40% in livers with potentially impaired function e.g. resulting from prior systemic therapy induction or bile duct colonization / transpapillary biliary drainage, or <50% in livers with severely impaired function resulting from liver cirrhosis (max. Child Pugh A5) OR function on hepatobiliary scintigraphy (HEBIS) is < 2.7 %/min/m2;
- •Age ≥ 18 years;
- •Able to understand the trial and provide informed consent.
排除标准
- •Liver cirrhosis with a Child-Pugh score of B or C;
- •Presence of portal hypertension;
- •Presence of cholangitis;
- •Pregnant women;
- •Premenopausal females not able/willing to commit to contraception (specifically long-acting reversible contraception or hormonal contraception);
- •Patients unresectable due to prohibitive comorbidities (decision made by local multidisciplinary team);
- •Patients with hepatic malignancies other than iCCC, pCCC or HCC;
- •PVE/HVE anatomically not feasible;
- •Any patient with non-resectable or non-ablatable extrahepatic metastatic disease.
- •Unable to understand the study information, study instructions and give informed consent
结局指标
主要结局
Overall survival
时间窗: 5 years
survival data will be recorded up to 5-years
Resectability 3 weeks after embolisation
时间窗: 3 weeks
The FLR is considered sufficient for resection 3 weeks after embolisation. Definition resectable: Patients are deemed resectable if the FLR is ≥30% in normally functioning livers, ≥40% in livers with potentially impaired function (e.g. resulting from prior systemic therapy or bile duct colonization / transpapillary biliary drainage), or ≥50% in livers with severely impaired function resulting from liver cirrhosis (max. Child Pugh A5) OR for any FLR volume, function on hepatobiliary scintigraphy is \> 2.7 %/min/m2
次要结局
未报告次要终点