Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Disease Progression
研究概览
简要总结
This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.
详细描述
This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin < 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.
The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.
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
- •HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines
- •Eastern Cooperative Oncology Group score 0 - 1
- •Child-Pugh A - B
- •Bilirubin < 2.5 mg/dL
- •Creatinine < 2.0 mg/dL
- •No prior liver-directed therapy or systemic therapy for HCC
- •Solitary, unresectable HCC ≤ 3cm
- •Albumin level < 3.4 g/dL at HCC diagnosis
- •Tumor anatomical location and angiosome amendable to MWA and 90Y
排除标准
- •Pregnant women
- •Concurrent malignancy
结局指标
主要结局
Disease Progression
时间窗: 1-year
Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm
次要结局
- Duration of Response(1 year)
- Time to Retreatment(1 year)
- Target Response Evaluation Criteria in Solid Tumors modified for HCC(60 - 120 days post-treatment)