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Compares treatment options for Hepato Cellular Carcinoma (HCC)
Official title Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)
ClinicalTrials.gov ID: NCT06990659
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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])...
- 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...
You likely can't join 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...
- 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...
- Patient previously included in the study
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Besançon, France
- Bobigny, France
- Brest, France
- Clichy, France
- La Roche-sur-Yon, France
- La Tronche, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Nice, France
- Paris, France
- Pessac, France
- Toulouse, France
- Villejuif, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Besançon, France; Bobigny, France; Brest, France; Clichy, France and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.