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临床试验/NCT02301091
NCT02301091Unknown3 期

Combine Transcatheter Arterial Embolization and Radiofrequency Ablation Versus Transcatheter Arterial Embolization Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Ming Zhao1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
240
试验地点
1
主要终点
Overall survival rates

研究概览

简要总结

The purpose of this study is to determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC and portal vein tumor thrombus.

详细描述

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second most common cause of death from cancer globally. Although the development of imaging techniques has improved early HCC diagnosis, portal vein tumor thrombus (PVTT) is still identified in 12.5-39.7% of HCC patients at their initial visits. Patients suffering from extremely aggressive HCC with PVTT have a median survival time of only 2.7-4.0 months if left untreated. The current standard of practice recommends sorafenib, which has been shown to prolong overall survival (OS) by nearly 3 months in advanced HCC patients and by 1.5-3.2 months in those with PVTT.

Transarterial chemoembolization (TACE) is the main treatment modality for unresectable HCC patients. Some recent prospective studies have demonstrated that TACE can serve as a safe and effective procedure in selected HCC patients with PVTT. TACE is recommend for a part of patients with HCC and PVTT by the treatment guidelines in China and Japan. However,due to the poor blood supplement of PVTT,the local control rate of PVTT after TACE treatment is low. Besides,as to some hypovascular intrahepatic tumors, TACE also could not controlled effectively. As regard to the high local control rate of radiofrequency ablation (RFA) for intrahepatic lesions and PVTT reported in some studies, we thus suggested that the combination of TACE and RFA might have higher tumor control rate and survival benefit than TACE alone.

We design this study to compare survival outcomes of TACE plus RFA and TACE alone in patients with HCC and PVTT.A total of 240 patients are needed according to statistician's calculation.They will be divided into two groups randomly by computer after sign the informed consent form.One group of patients received TACE plus RFA and the other group of patients received TACE alone.After treatment,patients will be followed-up on their survival, tumor response and adverse events.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HCC with portal vein tumor thrombus in the first or second branch
  • Refused sorafenib or could not tolerate the adverse effect of sorafenib
  • A solitary HCC ≤ 5.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 5.0 cm in diameter
  • Eastern Cooperative Oncology Group Performance Status 0-1
  • Child-Pugh Score ≤ 8
  • A platelet counts of > 60,000/mm3, hemoglobin>8.5 g/dL, prothrombin time prolong <6s
  • Albumin >2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase(AST)<5 times of upper limit
  • Sign the informed consent.

排除标准

  • Presence of extrahepatic metastasis except lymph node metastasis
  • The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
  • Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;
  • Severe heart, brain or kidney diseases
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC
  • Pregnant women or lactating women.

研究组 & 干预措施

TACE-RFA

Experimental

2 times TACE first, RFA for residual viable tumors and PVTT within 1 month.

干预措施: TACE (Procedure)

TACE-RFA

Experimental

2 times TACE first, RFA for residual viable tumors and PVTT within 1 month.

干预措施: RFA (Procedure)

TACE-RFA

Experimental

2 times TACE first, RFA for residual viable tumors and PVTT within 1 month.

干预措施: pirarubicin,mitomycin and lobaplatin (Drug)

TACE alone

Active Comparator

repeated TACE and 1 to 2 months interval between two sessions of TACE.

干预措施: TACE (Procedure)

TACE alone

Active Comparator

repeated TACE and 1 to 2 months interval between two sessions of TACE.

干预措施: pirarubicin,mitomycin and lobaplatin (Drug)

结局指标

主要结局

Overall survival rates

时间窗: 1 year

次要结局

  • Response rate of PVTT(6 months)
  • Progression-free survival rates(6 months)
  • Number of participants with adverse events(1 month)

研究者

发起方
Ming Zhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ming Zhao

Chief physician in Minimally Invasive Interventional Division,Medical Imaging Center,Sun Yat-sen University Cancer Center

Sun Yat-sen University

研究点 (1)

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