Effect of peretinoin on recurrence of hepatocellular carcinoma (HCC): Results of a phase II/III randomized placebo-controlled trial.
Effect of peretinoin on recurrence of hepatocellular carcinoma (HCC): Results of a phase II/III randomized placebo-controlled trial.
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Peretinoin 对肝细胞癌 (HCC) 复发的影响：II/III 期随机安慰剂对照试验的结果。
DOI：
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发表时间：
2010
期刊：
影响因子：
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通讯作者：
M. Makuuchi
中科院分区：
文献类型：
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作者：
K. Okita;O. Matsui;H. Kumada;Katsuaki Tanaka;S. Kaneko;H. Moriwaki;N. Izumi;T. Okusaka;Y. Ohashi;M. Makuuchi
背景：肝细胞癌是一种预后差、导致死亡的癌症，治疗后复发率高。目前还没有针对肝细胞癌复发的有效治疗方法。Peretinoin(PER)是一种建议用于治疗肝癌的非环类维甲酸(Muto等人)。1996年)。然而，由于样本量较小，早期结果需要证实。我们在GCP下进行了II/III期试验，以评估其疗效和剂量-反应关系。方法：符合条件的患者(n=401)为丙型肝炎病毒(丙型肝炎病毒)阳性患者，因初次肝癌或首次复发而接受根治性治疗(切除或消融)，且为Child-Pugh A或B级，随机分为600 mg(H；124)、300 mg(L，n=126)和安慰剂(P；n=127)进行多中心双盲试验。肝细胞癌的治愈和复发由盲目集中成像委员会每12周进行一次d-CT检查。主要终点为无复发生存期(RFS)。假设复发率为30%/年，危险比(HR)为0.60-0.65，则需要180-200个事件。给药期...
4024 Background: HCC is a poor prognosis cancer leading to death, with high rate of recurrence after curative therapy. No effective therapy for HCC recurrences has been established. Peretinoin (Per) is an acyclic retinoid suggested the efficacy for HCC (Muto et al. 1996). However, the early results require confirmation due to the small sample size. We conducted a phase II/III trial under GCP to evaluate its efficacy and dose-response relationship. Methods: Eligible patients (n = 401) were HCV (+), underwent curative therapy (resection or ablation) for initial HCC or first recurrence, and were Child-Pugh A or B, were randomized to 600 mg (H; n = 124), 300 mg (L; n = 126), or placebo (P; n = 127) in a multicenter, double-blind trial. Cures and recurrences of HCC were confirmed by d-CT every 12 wks by the blinded centralized image committee. Primary endpoint was recurrence free survival (RFS). Assuming a recurrence rate of 30%/yr and hazard ratio (HR) of 0.60-0.65, 180-200 events were required. Dosing period...