Overview

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.

Eligibility

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