{"title":"岩藻糖聚糖改善不可切除肝细胞癌TACE患者的肿瘤控制和肝功能:一项随机试验。","authors":"Yanting Zou, Szu-Yuan Wu, Wanqin Zhang, Wei Zhang, Xizhong Shen, Xudong Qu, Qunyan Yao","doi":"10.1111/liv.70347","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality. Transarterial chemoembolization (TACE) is the standard locoregional therapy for unresectable HCC but is limited by high recurrence and hepatic toxicity. Low-molecular-weight fucoidan (LMF), a sulfated polysaccharide from brown seaweed, has anticancer and hepatoprotective properties. This study assessed whether LMF enhances tumour response and preserves liver function when combined with TACE.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>In this randomised, double-blind, placebo-controlled trial, 82 patients with unresectable HCC were randomly assigned (1:1) to receive LMF (4.4 g twice daily) or placebo for 6 months in addition to TACE. Tumour response was assessed using modified RECIST criteria, and liver function was monitored via Child–Pugh classification. The primary endpoint was disease control rate (DCR), with objective response rate (ORR), liver function and adverse events as secondary endpoints.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Baseline characteristics were well balanced. DCR was significantly higher in the LMF group (95.24% vs. 80.00%, <i>p</i> = 0.035), with a lower progressive disease rate (4.76% vs. 20.00%). ORR was higher in the LMF group (52.38% vs. 35.00%) but not statistically significant (<i>p</i> = 0.1129). LMF preserved liver function (<i>p</i> = 0.029), with more patients maintaining Child–Pugh Class A (80.95% vs. 62.50%). Adverse event rates were similar, and no severe adverse events occurred.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>LMF improved tumour control, preserved liver function and had a favourable safety profile. These findings suggest LMF may mitigate TACE-related hepatic toxicity and prolong treatment eligibility, warranting further validation in larger trials.</p>\n </section>\n </div>","PeriodicalId":18101,"journal":{"name":"Liver International","volume":"45 10","pages":""},"PeriodicalIF":5.2000,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12442522/pdf/","citationCount":"0","resultStr":"{\"title\":\"Fucoidan Improves Tumour Control and Liver Function in TACE for Unresectable Hepatocellular Carcinoma: A Randomised Trial\",\"authors\":\"Yanting Zou, Szu-Yuan Wu, Wanqin Zhang, Wei Zhang, Xizhong Shen, Xudong Qu, Qunyan Yao\",\"doi\":\"10.1111/liv.70347\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality. Transarterial chemoembolization (TACE) is the standard locoregional therapy for unresectable HCC but is limited by high recurrence and hepatic toxicity. Low-molecular-weight fucoidan (LMF), a sulfated polysaccharide from brown seaweed, has anticancer and hepatoprotective properties. This study assessed whether LMF enhances tumour response and preserves liver function when combined with TACE.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>In this randomised, double-blind, placebo-controlled trial, 82 patients with unresectable HCC were randomly assigned (1:1) to receive LMF (4.4 g twice daily) or placebo for 6 months in addition to TACE. Tumour response was assessed using modified RECIST criteria, and liver function was monitored via Child–Pugh classification. The primary endpoint was disease control rate (DCR), with objective response rate (ORR), liver function and adverse events as secondary endpoints.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Baseline characteristics were well balanced. DCR was significantly higher in the LMF group (95.24% vs. 80.00%, <i>p</i> = 0.035), with a lower progressive disease rate (4.76% vs. 20.00%). ORR was higher in the LMF group (52.38% vs. 35.00%) but not statistically significant (<i>p</i> = 0.1129). LMF preserved liver function (<i>p</i> = 0.029), with more patients maintaining Child–Pugh Class A (80.95% vs. 62.50%). Adverse event rates were similar, and no severe adverse events occurred.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>LMF improved tumour control, preserved liver function and had a favourable safety profile. 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引用次数: 0
摘要
背景:肝细胞癌(HCC)是癌症相关死亡的主要原因。经动脉化疗栓塞(TACE)是不可切除HCC的标准局部治疗方法,但由于高复发和肝毒性而受到限制。低分子量褐藻多糖(LMF)是一种来自褐藻的硫酸酸化多糖,具有抗癌和保护肝脏的特性。本研究评估LMF联合TACE是否能增强肿瘤反应并保持肝功能。方法:在这项随机、双盲、安慰剂对照试验中,82例不可切除的HCC患者被随机分配(1:1)接受LMF (4.4 g,每日两次)或安慰剂,为期6个月。采用改良的RECIST标准评估肿瘤反应,并通过Child-Pugh分级监测肝功能。主要终点为疾病控制率(DCR),次要终点为客观缓解率(ORR)、肝功能和不良事件。结果:基线特征平衡良好。LMF组DCR显著高于对照组(95.24% vs. 80.00%, p = 0.035),进展性疾病发生率较低(4.76% vs. 20.00%)。LMF组的ORR较高(52.38% vs. 35.00%),但无统计学意义(p = 0.1129)。LMF保留了肝功能(p = 0.029),更多的患者维持Child-Pugh A级(80.95%比62.50%)。不良事件发生率相似,未发生严重不良事件。结论:LMF改善了肿瘤控制,保留了肝功能,并具有良好的安全性。这些发现表明,LMF可能减轻tace相关的肝毒性,延长治疗资格,需要在更大规模的试验中进一步验证。
Fucoidan Improves Tumour Control and Liver Function in TACE for Unresectable Hepatocellular Carcinoma: A Randomised Trial
Background
Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality. Transarterial chemoembolization (TACE) is the standard locoregional therapy for unresectable HCC but is limited by high recurrence and hepatic toxicity. Low-molecular-weight fucoidan (LMF), a sulfated polysaccharide from brown seaweed, has anticancer and hepatoprotective properties. This study assessed whether LMF enhances tumour response and preserves liver function when combined with TACE.
Methods
In this randomised, double-blind, placebo-controlled trial, 82 patients with unresectable HCC were randomly assigned (1:1) to receive LMF (4.4 g twice daily) or placebo for 6 months in addition to TACE. Tumour response was assessed using modified RECIST criteria, and liver function was monitored via Child–Pugh classification. The primary endpoint was disease control rate (DCR), with objective response rate (ORR), liver function and adverse events as secondary endpoints.
Results
Baseline characteristics were well balanced. DCR was significantly higher in the LMF group (95.24% vs. 80.00%, p = 0.035), with a lower progressive disease rate (4.76% vs. 20.00%). ORR was higher in the LMF group (52.38% vs. 35.00%) but not statistically significant (p = 0.1129). LMF preserved liver function (p = 0.029), with more patients maintaining Child–Pugh Class A (80.95% vs. 62.50%). Adverse event rates were similar, and no severe adverse events occurred.
Conclusions
LMF improved tumour control, preserved liver function and had a favourable safety profile. These findings suggest LMF may mitigate TACE-related hepatic toxicity and prolong treatment eligibility, warranting further validation in larger trials.
期刊介绍:
Liver International promotes all aspects of the science of hepatology from basic research to applied clinical studies. Providing an international forum for the publication of high-quality original research in hepatology, it is an essential resource for everyone working on normal and abnormal structure and function in the liver and its constituent cells, including clinicians and basic scientists involved in the multi-disciplinary field of hepatology. The journal welcomes articles from all fields of hepatology, which may be published as original articles, brief definitive reports, reviews, mini-reviews, images in hepatology and letters to the Editor.