Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)

ClinicalTrials.gov ID

NCT06990659

Lead Sponsor

University Hospital, AngersOTHER_GOV

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

206Estimated

Last Update Posted

Jul 17, 2026Actual

Start Date

Dec 18, 2025Actual

Primary Completion Date

Dec 17, 2027Estimated

Completion Date

Dec 17, 2028Estimated

Official Title

CHOC - Implementation and Evaluation of an Ambulatory Care Pathway for Intra-arterial Treatment of Primary Liver Cancer: Study Protocol for a Multicentre Randomised Controlled Hybrid Type 1 Trial 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

Brief Summary

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.

• Hepato Cellular Carcinoma (HCC)
• Intrahepatic Cholangiocarcinoma

• Ambulatory care
• Conventional inpatient care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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.

• Patient with HCC or iCCA eligible for intra-arterial treatment (transarterial chemoembolization [TACE] or transarterial radioembolization [TARE]), with no prior intra-arterial treatment of the same type as the one planned in the trial:

  • no prior TACE for patients included for TACE;
  • no prior TARE for patients included for TARE. Prior intra-arterial treatment of the other type is allowed (prior TACE before TARE, or prior TARE before TACE). Prior non-intra-arterial treatments are allowed.

• If TACE is proposed at the multidisciplinary tumour board (RCP):

  • Patient Child-Pugh < B8
  • Single or multiple HCC
  • Absence of lobar or truncal portal obstruction
  • Absence of bile duct dilatation

• If treatment by TARE 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; sequential (non-same-day) treatments are 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

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, AngersOTHER_GOV

Collaborators

Université Paris CitéOTHER

chaube@chu-angers.fr+33(0)24 135 4281

calame.paul@gmail.com+33(0)38 166 8244

olivier.sutter@aphp.fr+33(0)14 895 5555

jean-romain.risson@chu-brest.fr+33(0)29 834 7476

jules.gregory@aphp.fr+33(0)14 087 5344

nadia.moussa@ght85.fr+33(0)25 144 6049

jghelfi@chu-grenoble.fr+33(0)47 676 7575

xadhoute@hopital-saint-joseph.fr+33(0) 491 808 213

mathieu.rostam@chu-nantes.fr+33(0)240 083 333

chevallier.p@chu-nice.fr+33(0)49 203 6350

lorenzo.garzelli@aphp.fr+33(0) 642 530 068

charles.roux@aphp.fr+33(0)14 216 5545

maxime.barat@aphp.fr+33(0)15 841 2469

panteleimon.papadopoulos@chu-bordeaux.fr+33(0)55 679 5679

mokrane.fz@chu-toulouse.fr+33(0) 561 322 851

paul.beunon@gustaveroussy.fr+33(0)14 211 5428

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