Status:
NOT_YET_RECRUITING
Outpatient Care Pathway for Patients Treated Intra-arterially for Primary Liver Cancer
Lead Sponsor:
University Hospital, Angers
Collaborating Sponsors:
Université Paris Cité
Conditions:
Hepato Cellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized trial comparing two care organizations (outpatient versus conventional inpatient care) using a mixed method (quantitative and qualitative data and analysis). The protocol involves randomiz...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- HCC or CCi diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven.
- HCC or CCi naive to intra-arterial treatment. HCC 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 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 CCi)
- 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
- Technical contraindication or morphological elements of predictable technical difficulty
- Chronic renal insufficiency (Clairance \< 30 ml/min)
- Known allergy to a contrast agent or chemotherapy agent
- Patient unable to be a candidate for outpatient management
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT06990659
Start Date
December 1 2025
End Date
June 30 2028
Last Update
November 19 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
University hospital of Amiens
Amiens, France, 80054
2
University hospital of Angers
Angers, France, 49933
3
University hospital of Besançon
Besançon, France, 25030
4
Hospital of Avicennes (AP-HP)
Bobigny, France