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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
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注册号：

Registration number：

 ChiCTR2500114608 

最近更新日期：

Date of Last Refreshed on：

 2025-12-15 16:45:39 

注册时间：

Date of Registration：

 2025-12-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

Treatment selection by 3D bioprinting liver model to prevent liver cancer recurrence

English Acronym：

Treatment selection by 3D bioprinting liver model to prevent liver cancer recurrence

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Albert Chan 

研究负责人：

Albert Chan 

Applicant：

Albert Chan 

Study leader：

Albert Chan 

申请注册联系人电话：

Applicant telephone：

 +852 2255 3025

研究负责人电话：

Study leader's
telephone：

+852 2255 3025

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 acchan@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 acchan@hku.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

L340, Block L, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

研究负责人通讯地址：

L340, Block L, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Applicant address：

L340, Block L, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Study leader's address：

L340, Block L, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Department of Surgery, The University of Hong Kong

Applicant's institution：

Department of Surgery, The University of Hong Kong

研究负责人所在单位：

Department of Surgery, The University of Hong Kong

Affiliation of the Leader：

Department of Surgery, The University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 UW25-514

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

The Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster

Name of the ethic committee：

The Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-24 00:00:00

伦理委员会联系人：

Jenny Ng

Contact Name of the ethic committee：

Jenny Ng

伦理委员会联系地址：

Room 901, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Contact Address of the ethic committee：

Room 901, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2255 4086

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Department of Surgery, The University of Hong Kong

Primary sponsor：

Department of Surgery, The University of Hong Kong

研究实施负责（组长）单位地址：

2/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Primary sponsor's address：

2/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Department of Surgery

具体地址：

2/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Institution
hospital：

The University of Hong Kong

Address：

2/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Liver cancer  

Target disease：

Liver cancer

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

病例研究 

Study design：

Case study 

研究目的：

To evaluate the efficacy of biomimetic 3D bioprinting technology in guiding the selection of optimal adjuvant treatment regimens to prevent hepatocellular carcinoma (HCC) recurrence after curative liver resection.  

Objectives of Study：

To evaluate the efficacy of biomimetic 3D bioprinting technology in guiding the selection of optimal adjuvant treatment regimens to prevent hepatocellular carcinoma (HCC) recurrence after curative liver resection.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1.Non-HCC diagnosis, including fibrolamellar HCC, sarcomatoid HCC, mixed HCC cholangiocarcinoma etc; 2.Fail to give consent or refusal to take part in the study; 3.Child-Pugh class C liver cirrhosis; 4.Receipt of any prior systemic therapy for HCC.

Exclusion criteria：

1.Non-HCC diagnosis, including fibrolamellar HCC, sarcomatoid HCC, mixed HCC cholangiocarcinoma etc; 2.Fail to give consent or refusal to take part in the study; 3.Child-Pugh class C liver cirrhosis; 4.Receipt of any prior systemic therapy for HCC.

研究实施时间：

Study execute time：

从 From 2025-12-15 00:00:00至 To 2030-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-15 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

single arm

样本量：

 20

Group：

single arm

Sample size：

干预措施：

none

干预措施代码：

Intervention：

none

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Queen Mary Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Queen Mary Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Efficacy of Live-in-Cube in guiding the selection of optimal adjuvant treatment

指标类型：

主要指标

Outcome：

Efficacy of Live-in-Cube in guiding the selection of optimal adjuvant treatment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Recurrence rate

指标类型：

主要指标

Outcome：

Recurrence rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Disease free survival

指标类型：

次要指标

Outcome：

Disease free survival

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Overall survival

指标类型：

次要指标

Outcome：

Overall survival

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Liver tissue

组织：

Sample Name：

Liver tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

Tumour tissue

组织：

Sample Name：

Tumour tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

Blood

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

None

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

No IPD sharing

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No IPD sharing

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Collected personal and study data will be stored in a password protected, encrypted database with the study team permanently, and the principal investigator will be responsible for the safekeeping. Only study team and investigators can have right to gain access to the data. Collected biological samples will also be stored permanently as well. All collected data and biological samples, including personal data, study data, tissue and blood samples, will be stored permanently for future review and future liver cancer research. Unused biological samples will be destroyed and discarded upon request, however, the results will remain a part of the overall research data if part of the tissue has been proceeded

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Collected personal and study data will be stored in a password protected, encrypted database with the study team permanently, and the principal investigator will be responsible for the safekeeping. Only study team and investigators can have right to gain access to the data. Collected biological samples will also be stored permanently as well. All collected data and biological samples, including personal data, study data, tissue and blood samples, will be stored permanently for future review and future liver cancer research. Unused biological samples will be destroyed and discarded upon request, however, the results will remain a part of the overall research data if part of the tissue has been proceeded

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-12-15 16:45:11
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