Informations générales (source: ClinicalTrials.gov)

NCT06990659 En recrutement IDF
CHOC - Implémentation et évaluation d'un Parcours de Soin Ambulatoire Pour Les Patients traités Par Voie Intra-artérielle d'un Cancer Primitif du Foie : Essai Multicentrique contrôlé randomisé
Interventional
  • Carcinome hépatocellulaire
  • Satisfaction des patients
  • Cholangiocarcinome
N/A
University Hospital, Angers (Voir sur ClinicalTrials)
décembre 2025
décembre 2028
09 mai 2026
Randomized multicentre trial comparing two care organisations (ambulatory vs conventional inpatient) for patients undergoing transarterial chemoembolization (TACE) or radioembolization (TARE) for primary liver cancer (Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA)). Patients are followed for 7 months to assess patient satisfaction, safety and clinical outcomes. A qualitative implementation study and a medico-economic evaluation (cost analysis and 5-years budget impact analysis) are embedded to assess acceptability, adoption, feasability, and sustainability and to inform scaling.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY Paul BEUNON En recrutement IDF 29/05/2026 15:55:05  Contacter
CLCC INSTITUT GUSTAVE ROUSSY Paul BEUNON En recrutement IDF 30/04/2026 08:50:04  Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Avicenne Olivier SUTTER, Dr Contact (sur clinicalTrials)
AP-HP - Hôpital Avicenne Olivier SUTTER, Dr Contact (sur clinicalTrials)
AP-HP - Hôpital Beaujon Jules GREGORY, Dr Contact (sur clinicalTrials)
AP-HP - Hôpital Beaujon Jules GREGORY, Dr Contact (sur clinicalTrials)
AP-HP - Hôpital Cochin BARAT Maxime, Dr Contact (sur clinicalTrials)
AP-HP - Hôpital Cochin BARAT Maxime, Dr Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY Paul BEUNON, Dr Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
University hospital of Besançon - 25030 - Besançon - France Paul CALAME, Dr Contact (sur clinicalTrials)
University hospital of Besançon - 25030 - Besançon - France Paul CALAME, Dr Contact (sur clinicalTrials)
University hospital of Grenoble-Alpes - 38700 - La Tronche - France Julien GHELFI, Dr Contact (sur clinicalTrials)
University hospital of Grenoble-Alpes - 38700 - La Tronche - France Julien GHELFI, Dr Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hospital of Pitié-Salpétrière (AP-HP) - 75013 - Paris - France Charles ROUX, Dr Contact (sur clinicalTrials)
Hospital of Pitié-Salpétrière (AP-HP) - 75013 - Paris - France Charles ROUX, Dr Contact (sur clinicalTrials)
Hospital of Vendée - 85925 - La Roche-sur-Yon - France Nadia MOUSSA, Dr Contact (sur clinicalTrials)
Hospital of Vendée - 85925 - La Roche-sur-Yon - France Nadia MOUSSA, Dr Contact (sur clinicalTrials)
University hospital of Amiens - 80054 - Amiens - France Thierry YZET, Dr Contact (sur clinicalTrials)
University hospital of Amiens - 80054 - Amiens - France Thierry YZET, Dr Contact (sur clinicalTrials)
University hospital of Angers - 49933 - Angers - France Christophe AUBE, Pr Contact (sur clinicalTrials)
University hospital of Angers - 49933 - Angers - France Christophe AUBE, Pr Contact (sur clinicalTrials)
University hospital of Brest - 29609 - Brest - France Jean-Romain RISSON, Dr Contact (sur clinicalTrials)
University hospital of Brest - 29609 - Brest - France Jean-Romain RISSON, Dr Contact (sur clinicalTrials)
University hospital of Montpellier - 34090 - Montpellier - France Boris GUIU, Pr Contact (sur clinicalTrials)
University hospital of Montpellier - 34090 - Montpellier - France Boris GUIU, Pr Contact (sur clinicalTrials)
University hospital of Nice - 06202 - Nice - France Patrick CHEVALLIER, Dr Contact (sur clinicalTrials)
University hospital of Nice - 06202 - Nice - France Patrick CHEVALLIER, Dr Contact (sur clinicalTrials)
Univesity hospital of Bordeaux - 33607 - Pessac - France Panteleimon PAPADOPOULOS, Dr Contact (sur clinicalTrials)
Univesity hospital of Bordeaux - 33607 - Pessac - France Panteleimon PAPADOPOULOS, Dr Contact (sur clinicalTrials)

Critères

Tous


- Age ≥ 18 years

- HCC or iCCA diagnosed according to the criteria of the European Association for the
Study of the Liver (2024) or histologically proven.

- HCC or iCCA naive to intra-arterial treatment. HCC or iCCA may have been previously
treated with other non-intra-arterial therapies. Other HCC may have been previously
treated but not with intra-arterial therapy.

- If HCC ou iCCA treatment is proposed at a Multidisciplinary Consultation Meeting
(RCP):

- Patient Child-Pugh < B8

- Single or multiple HCC

- Absence of lobar or truncal portal obstruction

- Absence of bile duct dilatation

- If treatment by REH proposed in RCP:

- Absence of truncal portal tumor invasion

- Uni-lobar tumor invasion (except for centrohepatic iCCA)

- Total bilirubin < 20 mg/l (or 35 µmol/L)

- Patient affiliated to or benefiting from a social security scheme

- Patient having signed an informed consent form

Exclusion Criteria:


- Technical contraindication or morphological elements of predictable technical
difficulty

- Planned combined same day therapeutic strategies at the index procedure (e.g., TACE
combined with percutaneous ablation) are not allowed

- Chronic renal insufficiency (Clairance < 30 ml/min)

- Known allergy to a contrast agent or chemotherapy agent

- inability to participate in ambulatory care (inability to understand and follow
discharge instructions, lack of reliable telephone access, absence of a responsible
accompanying adult for the first night after discharge, or inability to access
urgent care in a timely manner if symptoms occur)

- Patient previously included in the study

- Patient who, for psychological, social, family or geographical reasons, could not be
regularly monitored, patient who, for psychological, social, family or geographical
reasons, could not be followed regularly

- Concomitant disease or severe uncontrolled clinical situation

- Severe uncontrolled infection

- Pregnant, breast-feeding or parturient woman

- Person deprived of liberty by judicial or administrative decision

- Person under compulsory psychiatric care

- Person under a legal protection measure

- Person unable to give consent