- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Albert Chan
- Telefonnummer: +852 2255 6646
- E-post: hbptrial@hku.hk
Studiesteder
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-
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Hong Kong, Hong Kong
- Rekruttering
- Queen Mary Hospital
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Ta kontakt med:
- Albert Chan
- Telefonnummer: +852 2255 6646
- E-post: hbptrial@hku.hk
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
HCC patients who are going to receive liver resection or ablation with a higher risk of tumour recurrence
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of patients have expected result
Tidsramme: 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
Tidsramme: within 3 years after surgery
|
Recurrence rate |
within 3 years after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
length of time that patients alive
Tidsramme: within 3 years after surgery
|
overall survival |
within 3 years after surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdomsattributter
- Neoplasmer etter histologisk type
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Neoplasmer i leveren
- Karsinom
- Patologiske tilstander, tegn og symptomer
- Tilbakefall
- Karsinom, hepatocellulært
Andre studie-ID-numre
- UW25-514
Plan for individuelle deltakerdata (IPD)
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