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Treatment Selection by 3D Bioprinting Liver Model to Prevent Liver Cancer Recurrence

2026年9月23日 更新者:Albert Chi Yan Chan、The University of Hong Kong

Implementation of Biomimetic 3D Bioprinting Technology in Selecting Optimal Regimens as Adjuvant Therapy to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection or Ablation: a Feasibility Study

This study is a feasibility study about a test on adjuvant therapy for patients in hepatocellular carcinoma (HCC) with a higher risk of tumour recurrence after liver resection or ablation. By collecting individual patient's liver and tumour tissue during surgical operation, 3D bioprinting technology will be adopted to construct patient-specific biomimetic liver models -'Liver-in-Cube', to test and identify the most effective adjuvant therapy for individual patients, thereby personalising treatment and improving treatment outcomes, and hence reducing the recurrence rate of HCC.

This is a phase II, non-randomised, open-label, single-centre, prospective feasibility study designed to evaluate the use of biomimetic 3D bioprinting technology in guiding the selection of adjuvant treatment regimens to prevent hepatocellular carcinoma (HCC) recurrence after curative liver resection. The study will be conducted at Queen Mary Hospital as a 5 years project.

A total of 20 HCC patients who are going to receive liver resection or ablation with a higher risk of tumour recurrence will be recruited. Patients will be identified from clinic and asked if willing to participate in the study. Consent will be signed before operation. Biological samples such as tissue and blood samples will be collected during operation for Liver-in-Cube construction. Patients will receive standard post operative care upon discharge, follow-up in clinic regularly as usual, and be referred to collaborated oncologists for adjuvant therapy. A 1-month post operative scan will also be arranged as standard procedure to confirm the post operative disease status. Result from Liver-in-Cube will be treated as an additional information about adjuvant therapy in preventing HCC recurrence. Patients will discuss with oncologists and decide if to adopt adjuvant therapy or not for HCC recurrence prevention. During the follow-up period, blood samples will also be collected for laboratory analysis outside the routine blood assessment.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

20

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

  • 姓名:Albert Chan
  • 电话号码:+852 2255 6646
  • 邮箱:hbptrial@hku.hk

学习地点

      • Hong Kong、香港
        • 招聘中
        • Queen Mary Hospital
        • 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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

HCC patients who are going to receive liver resection or ablation with a higher risk of tumour recurrence

描述

Inclusion Criteria:

  • Age ≥ 18 years at the time of screening
  • Diagnosis of HCC
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
  • With or without prior locoregional therapy such as transarterial chemoembolisation (TACE), radiofrequency ablation (RFA), and stereotactic body radiation therapy (SBRT) before surgery - Meet any item indicating higher risk of tumour recurrence: any tumour size ≥ 5cm, number of tumour ≥ 3, presence of microvascular or marcovascular invasion, or poor tumour differentiation
  • No prior systemic therapy for HCC
  • No other active malignancies within 5 years, except malignancies with a negligible risk of metastasis or death (eg. 5-year overall survival rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or stage I uterine cancer
  • Willing and able to provide written informed consent for the collection and usage of biological samples

Exclusion Criteria:

  • Non-HCC diagnosis, including fibrolamellar HCC, sarcomatoid HCC, mixed HCC cholangiocarcinoma etc.
  • Fail to give consent or refusal to take part in the study
  • Child-Pugh class C liver cirrhosis
  • Receipt of any prior systemic therapy for HCC

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

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of patients have expected result
大体时间:within 3 years after surgery

Efficacy of Liver-in-Cube in guiding the selection of optimal adjuvant treatment. Eg. Liver-in-Cube suggests drug A for patient A, and patient A receives drug A for treatment, then see if drug A delivers a better response for patient A Time Frame: within 3 years after surgery

within 3 years after surgery
Number of patient who has tumour recurrence
大体时间:within 3 years after surgery

Recurrence rate

within 3 years after surgery

次要结果测量

结果测量
措施说明
大体时间
length of time that patients alive
大体时间:within 3 years after surgery

overall survival

within 3 years after surgery

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4月13日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2031年12月31日

研究注册日期

首次提交

2025年12月12日

首先提交符合 QC 标准的

2026年9月23日

首次发布 (实际的)

2026年9月24日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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