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

NCT07839767 | Recruiting

• 1 other identifier: UW25-514
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HCC - Hepatocellular Carcinoma

Keywords

Liver cube; liver-in-cube; liver model; bioprinting; drugs selection; recurrence; HCC; hepatocellular carcinoma; adjuvant therapy

Outcome Measures

Primary Outcomes (2)

• Number of patients have expected result

  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

  Recurrence rate

  within 3 years after surgery

Secondary Outcomes (1)

• length of time that patients alive

  within 3 years after surgery

Interventions

Liver-in-cube testing OTHER

Liver-in-cube technology will be used to test and identify the most effective adjuvant therapy for individual patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Albert Chan

CONTACT

+852 2255 6646; hbptrial@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: September 24, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)