Prospective, randomized, double-blind, multi-center, Phase III clinical study on transarterial chemoembolization (TACE) combined with Sorafenib versus TACE plus placebo in patients with hepatocellular cancer before liver transplantation - HeiLivCa [ISRCTN24081794].
Prospective, randomized, double-blind, multi-center, Phase III clinical study on transarterial chemoembolization (TACE) combined with Sorafenib versus TACE plus placebo in patients with hepatocellular cancer before liver transplantation - HeiLivCa [ISRCTN24081794].
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DOI：
10.1186/1471-2407-8-349
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发表时间：
2008-11-26
期刊：
影响因子：
3.8
通讯作者：
Schemmer, P.
中科院分区：
文献类型：
--
作者：
Hoffmann, K.;Glimm, H.;Radeleff, B.;Richter, G.;Heining, C.;Schenkel, I.;Zahlten-Hinguranage, A.;Schirrmacher, P.;Schmidt, J.;Buechler, M. W.;Jaeger, D.;von Kalle, C.;Schemmer, P.
在符合肝移植（LTx）条件的患者中，高达50%的患者发生肝细胞癌（HCC）疾病进展，导致从LTx等待名单中退出。经动脉化疗栓塞术（TACE）被用作桥接治疗，反应率差异很大。口服多激酶抑制剂索拉非尼可显著延长晚期肝细胞癌患者的总生存期和进展时间。HeiLivCa研究是一项双盲、对照、前瞻性、随机多中心III期试验。研究组A的患者将接受经动脉化疗栓塞加索拉非尼400 mg bid治疗。研究组B的患者将接受经动脉化疗栓塞加安慰剂治疗。共208例经组织学证实的肝细胞癌或根据EASL标准诊断的HCC患者将入组。将在60起事件后进行中期患者分析。将在120起事件时评价至进展时间作为主要终点（TTP）。次要终点是达到LTx的患者数量、疾病控制率、OS、无进展生存期、生活质量、毒性和安全性。由于TACE是LTx之前最广泛使用的HCC主要治疗方法，而索拉非尼是晚期HCC唯一经证实有效的全身治疗方法，因此联合收割机联合使用这两种治疗方法具有很强的合理性。本研究旨在揭示TACE+索拉非尼联合治疗相对于单纯TACE的潜在优效性，并探索肝细胞癌LTx前新辅助治疗的新概念。
Disease progression of hepatocellular cancer (HCC) in patients eligible for liver transplantation (LTx) occurs in up to 50% of patients, resulting in withdrawal from the LTx waiting list. Transarterial chemoembolization (TACE) is used as bridging therapy with highly variable response rates. The oral multikinase inhibitor sorafenib significantly increases overall survival and time-to-progression in patients with advanced hepatocellular cancer. The HeiLivCa study is a double-blinded, controlled, prospective, randomized multi-centre phase III trial. Patients in study arm A will be treated with transarterial chemoembolization plus sorafenib 400 mg bid. Patients in study arm B will be treated with transarterial chemoembolization plus placebo. A total of 208 patients with histologically confirmed hepatocellular carcinoma or HCC diagnosed according to EASL criteria will be enrolled. An interim patients' analysis will be performed after 60 events. Evaluation of time-to-progression as primary endpoint (TTP) will be performed at 120 events. Secondary endpoints are number of patients reaching LTx, disease control rates, OS, progression free survival, quality of live, toxicity and safety. As TACE is the most widely used primary treatment of HCC before LTx and sorafenib is the only proven effective systemic treatment for advanced HCC there is a strong rational to combine both treatment modalities. This study is designed to reveal potential superiority of the combined TACE plus sorafenib treatment over TACE alone and explore a new neo-adjuvant treatment concept in HCC before LTx.
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