SBRT Sequential TACE Combined With Sorafenib Versus Sorafenib Alone in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus：A Single-center Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) rate
研究概览
简要总结
To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
详细描述
HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.
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
- •Age >18 years
- •Child-Pugh score ≤ 7
- •Performance status: ECOG score ≤ 2
- •HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
- •the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
- •No previous therapy for HCC
- •at least one measurable target lesion according to RECIST 1.1
- •Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
- •Serum total bilirubin ≤ 2 x ULN
- •Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
- •Creatinine ≤ 1.5 x ULN
- •No plan for pregnancy or breast feeding. Active contraception.
- •Willing to give informed consent
排除标准
- •Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- •Complete obstruction of hepatic outflow
- •Uncontrolled ascites of hepatic encephalopathy
- •Prior liver transplantation
- •Positive for human immunodeficiency virus (HIV)
- •Active gastric or duodenal ulcer
- •Other uncontrolled comorbidities or malignancy
- •Inability to give informed consent
研究组 & 干预措施
SBRT + TACE + Sorafenib
SBRT sequential TACE combined with Sorafenib
干预措施: SBRT+TACE+Sorafenib (Radiation)
Sorafenib
Sorafenib 800 mg/day orally
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression-free survival (PFS) rate
时间窗: at 12 weeks after randomization
Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
次要结局
- Radiologic response rate(at 12 weeks after randomization)
- Overall patient survival rate(up to 2 years after randomization)
- Disease control rate(at 12 weeks and up to 2 years after randomization)
- Objective response rate(at 12 weeks and up to 2 years after randomization)