- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Albert Chan
- Telefonnummer: +852 2255 6646
- E-post: hbptrial@hku.hk
Studieorter
-
-
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Hong Kong, Hong Kong
- Rekrytering
- Queen Mary Hospital
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Kontakt:
- Albert Chan
- Telefonnummer: +852 2255 6646
- E-post: hbptrial@hku.hk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
HCC patients who are going to receive liver resection or ablation with a higher risk of tumour recurrence
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of patients have expected result
Tidsram: 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
Tidsram: within 3 years after surgery
|
Recurrence rate |
within 3 years after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
length of time that patients alive
Tidsram: within 3 years after surgery
|
overall survival |
within 3 years after surgery
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Sjukdomsegenskaper
- Neoplasmer efter histologisk typ
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Leversjukdomar
- Neoplasmer, körtel och epitel
- Adenocarcinom
- Neoplasmer i levern
- Carcinom
- Patologiska tillstånd, tecken och symtom
- Upprepning
- Karcinom, hepatocellulärt
Andra studie-ID-nummer
- UW25-514
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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