Adjuvant Therapies for Patients With HCC and MVI (A-TACE/S-HCC)
Adjuvant Transarterial Chemoembolization With or Without Sorafenib for Patients With Hepatocellular Carcinoma and Microvascular Invasion
Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Though prognosis for patients with HCC is generally poor, hepatic resection can be an effective curative treatment, and its indications have been expanding in recent years. Resection can be reasonably safe and effective even for patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as high as 74% for patients with intermediate and advanced HCC after resection. Microvascular invasion is one of the main risk factors which influence risk of HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after resection is so important to improve patient prognosis.
Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in reducing early recurrence rate and mortality for patients with HCC with risk factors of recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular invasion.
研究概览
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Guangxi
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Nanning、Guangxi、中国、530021
- 招聘中
- Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
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接触：
- Bang-De Xiang, MD,PhD
- 电话号码：86-771-5330855
- 邮箱：xiangbangde@163.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-75 years
- Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
- Patients with microvascular invasion by histopathological examination of surgical samples
- Patients have Child-Pugh A or B liver function
- No previous neoadjuvant treatment
- No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
- No malignancy other than HCC for 5 years prior to the initial HCC treatment
Exclusion Criteria:
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection
- Known Central Nervous System tumors including metastatic brain disease
- History of organ allograft
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：TACE
Transarterial chemoembolization (TACE) is performed two to four weeks after hepatic resection.
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TACE is performed one month after resection.
其他名称：
This group will not receive adjuvant therapy.
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有源比较器：sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection.
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Sorafenib is submitted one month after resection.
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其他：TACE plus sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection.
At the same time, TACE is performed two to four weeks after hepatic resection.
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This group will not receive adjuvant therapy.
TACE plus sorafenib will be submitted one month after resection.
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无干预：empty control
This group patients will receive best supportive care.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Overall survivals
大体时间：1 year
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1 year
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次要结果测量
结果测量 |
大体时间 |
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Hospital mortality
大体时间：30-day
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30-day
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Recurrence rates
大体时间：1 years
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1 years
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合作者和调查者
出版物和有用的链接
一般刊物
- Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
- Zhong JH, Li LQ. Postoperative adjuvant transarterial chemoembolization for participants with hepatocellular carcinoma: A meta-analysis. Hepatol Res. 2010 Oct;40(10):943-53. doi: 10.1111/j.1872-034X.2010.00710.x.
- Zhou L, Rui JA, Wang SB, Chen SG, Qu Q. Early recurrence in large hepatocellular carcinoma after curative hepatic resection: prognostic significance and risk factors. Hepatogastroenterology. 2014 Oct;61(135):2035-41.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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肝细胞癌的临床试验
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung） | 药物相关副作用和不良反应（MeSH术语） | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤（皮肤癌） | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung）意大利
TACE的临床试验
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Sun Yat-sen University主动，不招人
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Second Affiliated Hospital, School of Medicine,...尚未招聘肝细胞癌 (HCC) | 肝脏手术 | TACE | 乐伐替尼 | 辅助放化疗 | 人工智能
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Beijing Tsinghua Chang Gung Hospital未知
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First Affiliated Hospital, Sun Yat-Sen University完全的
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First Affiliated Hospital, Sun Yat-Sen University招聘中
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Zhongda Hospital尚未招聘
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Beijing Tsinghua Chang Gung Hospital未知