Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma (CATCH)
10. april 2019 oppdatert av: Rennes University Hospital
Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study
The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT).
Intention-to-treat analysis have showed that the reported excellent long-term outcome is curtailed and significantly hampered by the growing incidence of patients who must be removed from the waiting list because of tumor progression.
A way to face with this issue is to treat hepatocellular carcinoma prior to LT.
Among therapeutic options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most common modality used.
While there are many studies concerning TACE in this setting, none are controlled studies and thus there is no firm evidence concerning its efficacy in reducing drop-out or increasing survival.
Moreover TACE may induce risks (liver failure, arterial complications…) while waiting for LT.
Most of the available data have been based upon analysis of patients who received a transplant and have not included patients who were eligible for LT but died, or showed progression, before it could be performed.
Therefore, studies conducted on an intention-to-treat basis are needed to clarify the benefit and the risks of TACE prior to LT in patients with hepatocellular carcinoma.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
- Multicentre, prospective, randomized, 2 parallel group study
- Preoperative evaluation of hepatocellular carcinoma in recipients: Tumor diagnosis will be mainly based upon EASL guidelines. HCCs will be classified according to UCSF criteria (size, number of nodules). Clinical and biological status will be updated every 3 month.
- Pre-transplant treatment:
TACE group: An emulsion of Lipiodol and a cytotoxic drug (50mg/m2 of doxorubicin) will be injected as selectively as possible. Then, an embolic agent will be used to assure stop of flow. The first injection will be performed within 10 days following enlisting and repeated every 8 weeks until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response. Clinical/biological follow-up will be done once a month.
Control group (no treatment until LT): clinical/biological follow-up and CT-scan every 3 month.
This prospective, multicentric, and randomized study may allow investigators to show that TACE with DC-BeadsR can significantly increase intention to treat survival of patients transplanted for HCC. We also expect that this result will be associated with less recurrence of the cancer after transplantation.
Obviously, we expect that the beneficial effect of TACE will be associated with a acceptable rate of complication related to the procedure.
- Pathologic examination: In all patients in whom LT will be performed, the diagnosis of hepatocellular carcinoma will be confirmed by a histological examination of the explanted liver.
- Dropout criteria: Patients with progression but still meeting the transplant criteria will be maintained in their respective group. Patients with progression over the transplant criteria will be excluded from the waiting list and censored.
Studietype
Intervensjonell
Registrering (Faktiske)
7
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Créteil, Frankrike, 94010
- Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris
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Grenoble, Frankrike, 38000
- Hôpital Michalon, CHU de Grenoble
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Lille, Frankrike, 59000
- Hôpital Claude Huriez, CHU de Lille
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Lyon, Frankrike, 69000
- Hôpital de la Croix Rousse, HCL, Lyon
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Paris, Frankrike, 75000
- Hôpital Saint-Antoine / APHP
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Rennes, Frankrike, 35033
- Hôpital Pontchaillou
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Tours, Frankrike, 37000
- Hôpital Trousseau, CHU de Tours
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adult patients >18 years
- With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria
- Without general contraindication to LT
- Written informed consent.
Exclusion Criteria:
- Patients that already had TACE
- Or other local treatment for HCC
- Or neoadjuvant systemic chemotherapy
- Or planned living donor
- Or non arterialized lesion(s)
- Or Contraindication to DC-BeadsR
- Or allergy to contrast agents
- Or contraindication to Doxorubicin.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Styre
Vanlig omsorg
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Eksperimentell: Intra-arterial administration of DC BeadsR
Intra-arterial administration of DC BeadsR, (1 vial of 100-300 µm) as selectively as possible loaded with doxorubicin (50 mg per procedure) and mixed with an equal volume of contrast medium.
The first injection will be performed within 21 days following enlisting and repeated 1-2 times until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Survival
Tidsramme: 3 years
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Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma
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3 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Gjentakelsesfrekvens
Tidsramme: 3 år
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3 år
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Dropout rate
Tidsramme: 3 years
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Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)
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3 years
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Post-transplantation survival rate
Tidsramme: 3 years
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3 years
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Allograft survival
Tidsramme: 3 years
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3 years
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Time to dropout
Tidsramme: 3 years
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3 years
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TACE-induced complications (local and general)
Tidsramme: 3 years
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3 years
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Contrast agent - induced complications
Tidsramme: 3 years
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3 years
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Doxorubicin-induced complications
Tidsramme: 3 years
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3 years
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Efficacy of TACE
Tidsramme: 3 years
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Efficacy of TACE (morphological response to TACE: captation rate of Lipiodol and morphological response (RECIST guidelines), as well as histological criteria: percentage of necrosis on pathological examination)
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3 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Philippe COMPAGNON, MD, Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-Est
- Hovedetterforsker: Karim BOUDJEMA, MD PhD, Service de Chirurgie Hépato-biliaire et Digestive, Transplantation Hépatique / CHU de Rennes / Université de Rennes 1
- Studiestol: Bruno Laviolle, MD, PhD, Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2012
Primær fullføring (Faktiske)
28. mai 2014
Studiet fullført (Faktiske)
16. februar 2016
Datoer for studieregistrering
Først innsendt
28. august 2012
Først innsendt som oppfylte QC-kriteriene
28. august 2012
Først lagt ut (Anslag)
30. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. april 2019
Sist bekreftet
1. september 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2012~A00269-34
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