Comparing Re-trans-catheter Arterial Chemoembolization Versus Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma Patients Who Had Incomplete Response After Prior TACE (TASABR Trial): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- freedom form local progression
研究概览
简要总结
Till now, trans-arterial chemoembolization (TACE) is still one of the common modalities in treating hepatocellular carcinoma patients with unresectable intermediate stage. However, residual viable HCC after TACE is not uncommon, leading to a poor overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been reported to be potentially useful for curatively managing early-stage HCC in retrospective studies. Thus, conducting a randomized clinical trial to test the role of SABR in eradicating post-TACE residual tumors is therefore encouraged. The present phase-III trial intended to compare clinical outcomes between TACE + SABR and TACE + re-TACE for HCC patients with post-prior-TACE residual tumors.
详细描述
Developing effective treatment modalities is crucial in managing HCC patients with unresectable intermediate stage. Nowadays, many therapies have been used for treating this group of HCC patients, including TACE. However, residual tumors after TACE are not uncommon. In conventional, re-TACE is recommended for managing residual tumors. However, accumulated overall survival is still poor in consecutive TACEs, leading to a low rate of <20% in 5 years.
In this regard, radiotherapy has been proved to be effective in managing HCC patients, especially a novel technique named SABR. When compared with conventional-fractionated radiotherapy, SABR demonstrated better treatment responses with fewer side effects in managing primary or metastatic liver tumors. In the literature, phase I and II trials of TACE plus SABR showed excellent local control rates and promising 1- and 2-year survival rates. However, till now, there is no head-to-head comparison between TACE + SABR and consecutive TACEs.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a) Radiographic enhancing liver lesions with early enhance and delay wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
- •Genders: Both male and female
- •Barcelona Clinic Liver Cancer (BCLC) stage A to B
- •Child-Pugh A or B
- •Unresectable tumors or medically inoperable status or surgery was declined/refused.
- •Meets clinical criteria for eligibility for TACE or SABR
- •SABR can be applied within 6 weeks of registration
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •Life expectancy > 12 weeks
- •negative pregnancy
- •No prior treatment, except for surgical resection and radiofrequency ablation (RFA)
- •Hemoglobin ≧ 8.0 g/dL(may be post-transfusion if clinically indicated)
- •Total bilirubin ≦ 3.0 mg/dL
- •Aspartate aminotransferase (AST) ≦ 5x institutional upper limit of normal
- •Alanine transaminase (ALT) ≦ 5x institutional upper limit of normal
- •Absolute neutrophil count ≧ 1,000 /μl
- •Platelet count ≧ 20,000/μl (may be post-transfusion if clinically indicated)
- •Prothrombin time-international normalized ratio ≤ 1.7
排除标准
- •Previous TACE ≥ 2 times
- •Prior radiotherapy to the upper abdomen
- •Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for at least 3 years
- •metastatic disease
- •cardiac ischemia or stroke within last 6 months
- •medical or psychosocial condition unsuitable
- •History of sorafenib therapy within 21 days prior
结局指标
主要结局
freedom form local progression
时间窗: Up to 12 months
The freedom from local progression is defined as no in-field progressive disease. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
次要结局
- Grade of toxicity(Up to 24 months)
- Overall survival(Up to 24 months)
- Progression-free survival(Up to 24 months)
- Response rate(Up to 24 months)
- Duration of Response of the treated tumor(Up to 24 months)