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- Klinische proef NCT07839767
Treatment Selection by 3D Bioprinting Liver Model to Prevent Liver Cancer Recurrence
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Albert Chan
- Telefoonnummer: +852 2255 6646
- E-mail: hbptrial@hku.hk
Studie Locaties
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Hong Kong, Hongkong
- Werving
- Queen Mary Hospital
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Contact:
- Albert Chan
- Telefoonnummer: +852 2255 6646
- E-mail: hbptrial@hku.hk
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
HCC patients who are going to receive liver resection or ablation with a higher risk of tumour recurrence
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of patients have expected result
Tijdsspanne: within 3 years after surgery
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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
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Number of patient who has tumour recurrence
Tijdsspanne: within 3 years after surgery
|
Recurrence rate |
within 3 years after surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
length of time that patients alive
Tijdsspanne: within 3 years after surgery
|
overall survival |
within 3 years after surgery
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata per site
- Neoplasmata
- Ziekte attributen
- Neoplasmata per histologisch type
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Lever Ziekten
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Lever neoplasmata
- Carcinoom
- Pathologische aandoeningen, tekenen en symptomen
- Herhaling
- Carcinoom, hepatocellulair
Andere studie-ID-nummers
- UW25-514
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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