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

Recruiting now · Not applicable

Conditions studied: Hepato Cellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma

In brief

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.

Key facts

Study ID: NCT06990659
Run by: University Hospital, Angers
People needed: 206
Starts: 2025-12-18
Expected to finish: 2028-12-17
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Institut Gustave Roussy (IGR) — Villejuif, France (enrolling)
University hospital of Angers — Angers, France (enrolling)
University hospital of Besançon — Besançon, France (enrolling)
Hospital of Avicennes (AP-HP) — Bobigny, France (enrolling)
University hospital of Brest — Brest, France (enrolling)
Hospital of Beaujon (AP-HP) — Clichy, France (enrolling)
Hospital of Vendée — La Roche-sur-Yon, France (enrolling)
University hospital of Grenoble-Alpes — La Tronche, France (enrolling)
University hospital of Marseille (AP-HM) — Marseille, France (enrolling)
Saint-Joseph Hospital — Marseille, France (enrolling)
Hospital of Cochin (AP-HP) — Paris, France (enrolling)
University hospital of Toulouse — Toulouse, France (enrolling)
University hospital of Amiens — Amiens, France (enrolling)
University hospital of Nice — Nice, France (enrolling)
Saint-Antoine Hospital (AP-HP) — Paris, France (enrolling)
Hospital of Pitié-Salpétrière (AP-HP) — Paris, France (enrolling)
University hospital of Montpellier — Montpellier, France
University hospital of Nantes — Nantes, France
Univesity hospital of Bordeaux — Pessac, France

Full record on ClinicalTrials.gov

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