此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury

The goal of this study is to find out whether phycocyanin, a natural protein from spirulina, can help protect the liver and support recovery in adults having part of their liver removed. The study will also look at whether phycocyanin is safe to take.The main questions are:

Does phycocyanin reduce liver injury after surgery? Does it help the liver grow back and recover? What side effects or medical problems happen while taking it?

Researchers will compare phycocyanin with a placebo, which looks similar but does not contain phycocyanin. About 30 people will take part. Each person will be randomly placed into one of the two groups, and neither the participants nor the researchers will know which treatment each person receives during the study.

Participants will:

Take 1.5 grams of phycocyanin or placebo every day for 3 weeks before surgery and 3 weeks after surgery Receive the usual care for liver surgery Give blood and stool samples before and after treatment Allow researchers to study a small piece of liver tissue removed during surgery Return for follow-up for up to 90 days after surgery

The samples will be used to check liver function, inflammation, gut bacteria, and changes linked to liver healing. Possible side effects include an allergic reaction or stomach discomfort. The study has been approved by an ethics committee.

研究概览

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • 招聘中
        • The Second Affiliated Hospital of Zhejiang University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Diagnosis of intrahepatic cholangiocarcinoma
  • Child-Pugh class A liver function
  • Planned neoadjuvant treatment with gemcitabine plus oxaliplatin, lenvatinib, and a PD-1 inhibitor
  • Planned anatomical hemihepatectomy with an expected future liver remnant greater than 40%
  • Age 18 to 75 years
  • Willing and able to participate and provide written informed consent
  • No acute illness or significant worsening of symptoms within 4 weeks before enrollment

Exclusion Criteria:

  • Serious coexisting medical conditions
  • Known allergy to phycocyanin
  • Other malignant tumors
  • Previous liver resection
  • History of severe psychiatric illness that may affect treatment adherence

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Phycocyanin Group
Participants will take 1.5 grams of phycocyanin by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. They will also receive the usual medical care for partial liver removal surgery.
Participants will take 1.5 grams of phycocyanin by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery. Phycocyanin is a natural protein from spirulina.
安慰剂比较:Placebo Group
Participants will take 1.5 grams of maltodextrin placebo by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. The placebo does not contain phycocyanin. Participants will also receive the usual medical care for partial liver removal surgery.
Participants will take 1.5 grams of maltodextrin placebo by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery. The placebo does not contain phycocyanin.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in Serum Aspartate Aminotransferase (AST) Level
大体时间:Baseline and Week 3 after surgery
Baseline and Week 3 after surgery
Change in Serum Alanine Aminotransferase (ALT) Level
大体时间:Baseline and Week 3 after surgery
Baseline and Week 3 after surgery
Change in Serum Total Bilirubin (TBIL) Level
大体时间:Baseline and Week 3 after surgery
Baseline and Week 3 after surgery

次要结果测量

结果测量
大体时间
Change in Blood Inflammatory Marker Levels
大体时间:Baseline and Week 3 after surgery
Baseline and Week 3 after surgery
Liver Cell Proliferation Assessed by Ki-67 Expression
大体时间:Baseline and Week 3 after surgery
Baseline and Week 3 after surgery
Liver Cell Proliferation Assessed by PCNA Expression
大体时间:Baseline and Week 3 after surgery
Baseline and Week 3 after surgery

其他结果措施

结果测量
大体时间
Incidence of Treatment-Emergent Adverse Events
大体时间:through study completion, an average of 1 year
through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2029年5月30日

研究完成 (估计的)

2029年5月30日

研究注册日期

首次提交

2026年7月22日

首先提交符合 QC 标准的

2026年8月9日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月9日

最后验证

2026年7月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅