HepatocholangiocarcinomaFFCD-2205NCT06541652
A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers
An observational study of Hepatocholangiocarcinoma and Fibrolamellar Carcinoma, run by Federation Francophone de Cancerologie Digestive at 40 sites in France.
Trial summary
The aim of this French multicenter retrospective study is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocholangiocarcinoma, Fibrolamellar Carcinoma, Hepatic Epithelioid Hemangioendothelioma
- How many people
- 150 participants
- Where
- 40 sitesFrance
- Study dates
- 26 Mar 2024to Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the health centers, patients were identified in two ways: 1. via diagnoses obtained in the anatomopathology departments of each investigating center 2. via multidisciplinary consultation meetings on primary hepatic tumours/digestive oncology at each investigating center. Patients with a diagnosis of rare primary hepatic cancers diagnosed on or after 01/01/2018 may be included, whether alive or deceased at the time of registration in the CAPRIH cohort.
Who may be able to join
- 18 years of age or older,
- with histologically proven hepato-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma or hepatic angiosarcoma
- diagnosed after January 01, 2018 living or deceased at the time of registration in the cohort
- for living patients who have not objected to the research: (note of non-objection to be attached° agreeing to participate in ancillary studies must sign the biological consent form for participation in biological studies.
Who cannot join
- without social security
- No access to tumor block
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
France40 sites, 40 recruiting
- Recruiting
CHU Amiens picardie
Amiens, 80054
eric NGUYEN KHAC, MD, 03 22 66 89 47, nguyen-khac.eric@chu-amiens.fr
- Recruiting
Chu Angers
Angers, 49933
FREDERIC OBERTI, MD, 02 41 35 53 80, froberti@chu-angers.fr
- Recruiting
Ch - Centresimone Veil de Beauvais
Beauvais, 60021
HANIFA AMMARGUELLAT, MD, 03 44 11 21 22, h.ammarguellat@ch-beauvais.fr
- Not yet recruiting
Chu Jean Minjoz
Besançon
Angelique VIENOT, 03 81 66 83 41, angelique.vienot@gmail.com
- Not yet recruiting
Ch Bethune Beuvry
Béthune, 62408
Helene VAN DAMME, MD, 03 21 64 43 19, helene.vandamme@wanadoo.fr
- Recruiting
Avicenne
Bobigny, 93000
JEAN CHARLES NAULT, PR, 0148024149, naultjc@gmail.com
- Not yet recruiting
Cote de Nacre
Caen
Isabelle OLLIVIER HOURMAND, 02 31 06 45 44, ollivierhourmand-i@chu-caen.fr
- Recruiting
Centre Hospitalier
Calais
Nathalie IBRAHIM, 0321463431, n.ibrahim@ch-calais.fr
- Recruiting
Chu de Clichy Hopital Beaujon
Clichy, 92110
MOHAMED BOUATTOUR, MD, 01.40.87.54.87, mohamed.bouattour@aphp.fr
- Recruiting
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
HELENE REGNAULT, MD, 01 98 12 13 52, helene.regnault@aphp.fr
- Recruiting
CHU
Dijon, 21079
MARIANNE LATOURNERIE, MD, 03 80 29 37 50, marianne.latournerie@chu-dijon.fr
- Recruiting
Chu Grenobles Alpes
La Tronche, 38700
BLEUENN BRUSSET, MD, 04 76 76 66 87, bbrusset@chu-grenoble.fr
- Recruiting
Centre Hospital Universitaire de lille
Lille, 59000
Emmanuel Boleslawski, pr, 0320446364, emmanuel.boleslawski@chu-lille.fr
- Recruiting
Longjumeau Ch Nord Essone
Longjumeau
Manal AWAD, MD, 01 64 54 29 41, m.awad@gh-nord-essonne.fr
- Recruiting
Ch Edouard Herriot
Lyon, 69002
JEROME DUMORTIER, MD, 04 72 11 01 47, jerome.dumortier@chu-lyon.fr
- Recruiting
Centre Léon Berard
Lyon, 69008
aurelien dupre, 0478782933, aurelien.dupre@lyon.unicancer.fr
- Recruiting
La Clinique de La Sauvegarde
Lyon, 69009
BENJAMIN DARNIS, MD, 04 37 49 70 10, darnis@chirurgien-digestif.com
- Recruiting
Chu Edouard Herriot
Lyon
Jérôme DUMORTIER, 04 72 11 01 11, jerome.dumortier@chu-lyon.fr
- Recruiting
Lyon Cac Leon Berard
Lyon
Aurelien DUPRE, 04 78 78 27 51, aurelien.dupre@lyon.unicancer.fr
- Not yet recruiting
Lyon La Croix Rousse
Lyon
Philippe MERLE, 04 26 10 93 56, philippe.merle@chu-lyon.fr
- Recruiting
Hopital Saint Joseph
Marseille, 13285
XAVIER ADHOUTE, MD, 04 91 80 82 12, xadhoute@hopital-saint-joseph.fr
- Recruiting
Chu de La Timone
Marseille, 13385
RENE GEROLAMI, MD, 04 91 38 36 96, rene.gerolami@ap-hm.fr
- Recruiting
CHR - Metz Thionville Hopital de Mercy
Metz, 57085
Guillaume CONROY, 03 87 55 33 05, g.conroy@chr-metz-thionville.fr
- Not yet recruiting
CHU La Source
Orléans
Barbara DAUVOIS, 02 38 51 47 04, barbara.dauvois@chr-orleans.fr
- Recruiting
Chu de Paris Saint Antoine
Paris, 75571
MARIE LEQUOY, MD, 01 49 28 31 54, marielequoy@gmail.com
- Recruiting
AP - HP - Pitié Salpêtrière
Paris, 75651
MANON ALLAIRE, MD, 01 42 16 10 34, allama5@hotmail.fr
- Not yet recruiting
PAU CH
Pau, 64000
JULIETTE THAURY, 0559724983, juliette.thaury@ch-pau.fr
- Recruiting
Centre Hospitalier de Perpignan
Perpignan, 66046
Faiza Khemissa-Akouz, PhD, 33-4-6861-6751, fkhemissa@hotmail.com
- Recruiting
Hopital Haut Leveque
Pessac, 33604
JEAN FREDERIC BLANC, PR, 05 56 79 58 06, jean-frederic.blanc@chu-bordeaux.fr
- Recruiting
Chu de Poitiers
Poitiers, 86021
DAVID TOUGERON, PR, 05 49 44 38 35, david.tougeron@chu-poitiers.fr
- Recruiting
CH - Annecy Genevois
Pringy, 74374
Emmanuel Maillard, md, 04 50 63 66 05, emaillard@ch-annecygenevois.fr
- Recruiting
Chu Robert Debre
Reims, 51000
ELIA GIGANTE, MD, 0326789219, egigante@chu-reims.fr
- Not yet recruiting
CAC - Eugène Marquis
Rennes, 35042
JULIEN EDELINE, MD, 02 99 25 31 96, j.edeline@rennes.unicancer.fr
- Not yet recruiting
Ico Site Rene Gauducheau
Saint-Herblain, 44805
TIMOTHEE VIGNAUD, DR, 0240679984, timothee.vignaud@ico.unicancer.fr
- Recruiting
Hopital Nord Chu Saint Etienne
Saint-Priest-en-Jarez
Jean-Marc PHELIP, Pr, 04 77 82 86 19, j.marc.phelip@chu-st-etienne.fr
- Recruiting
Groupe Hospitalier Rance Emeraude
St-Malo, 35403
VIAUD JULIETTE, Dr, 02 99 21 29 80, juliette.viaud@gmail.com
- Recruiting
Chu Rangueil
Toulouse
Jean-Marie PERON, Pr, 05 61 77 94 83, peron.jm@chu-toulouse.fr
- Not yet recruiting
Chru de Tours
Tours, 37044
ANAIS JAILLAIS, MD, 02 47 47 47 47, a.jaillais@chu-tours.fr
- Not yet recruiting
Chu Paul Brousse
Villejuif
Olivier ROSMORDUC, olivier.rosmorduc@aphp.fr
- Not yet recruiting
Gustave Roussy
Villejuif
Alice BOILEVE, Dr, 0142112202, alice.boileve@gustaveroussy.fr
About this study
The aim of this French multicenter retrospective study is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences. This retrospective cohort will be the backbone of future translational studies aimed at identifying new molecular, histological, circulating and radiological tumor biomarkers, potentially useful at every stage of diagnosis and prognostic or theranostic evaluation.
Read the detailed description
The aim is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences.
- Conditions
- Hepatocholangiocarcinoma, Fibrolamellar Carcinoma, Hepatic Epithelioid Hemangioendothelioma, Hepatoblastoma, Hepatic Neuroendocrine Carcinoma, Hepatic Carcinosarcomas
- Keywords
- rare primary liver cancers, LIVER, HEPATIC, COHORT, RISK FACTORS
- Medical subject headings
- Liver Neoplasms, Fibrolamellar hepatocellular carcinoma, Hepatoblastoma, Cholangiocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the clinical, histological and radiological characteristics of various rare primary liver cancers
Description of the clinical, histological and radiological characteristics of various rare primary liver cancers
Measured: up to 5 years from the date of diagnosis
Secondary outcomes (3)
Recurrence-free survival (for non-metastatic patients)
Time interval between the date of disease diagnosis and the date of locoregional and/or metastatic recurrence or death (all causes). Patients alive and without recurrence will be censored at the date of last news
Measured: up to 5 years from diagnosis
Progression-free survival (for metastatic patients)
Time interval between the date of diagnosis of the disease and the date of radiological and/or clinical progression or death (all causes). Patients alive and progression-free will be censored at the date of last news.
Measured: up to 5 years from diagnosis
Overall survival
Time interval between the date of diagnosis of the disease and the date of death (from all causes). Living patients will be censored at the date of last news.
Measured: up to 5 years from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start26 Mar 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Responsible party
- Sponsor
- Investigators
- jean-charles nault, Pr, Principal investigator, Federation Francophone de Cancerologie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541652
- Sponsor's protocol ID
- CAPRIH COHORT
- Other IDs
- 2023-A01517-38
- Acronym
- FFCD-2205
- Status last verified
- Feb 2025
- First submitted
- 15 Jul 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers
- ClinicalTrials.gov ID
- NCT06541652
- Acronym / sponsor ID
- FFCD-2205 / CAPRIH COHORT
- Conditions
- Hepatocholangiocarcinoma, Fibrolamellar Carcinoma, Hepatic Epithelioid Hemangioendothelioma, Hepatoblastoma, Hepatic Neuroendocrine Carcinoma, Hepatic Carcinosarcomas
- Keywords
- rare primary liver cancers, LIVER, HEPATIC, COHORT, RISK FACTORS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this French multicenter retrospective study is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences. This retrospective cohort will be the backbone of future translational studies aimed at identifying new molecular, histological, circulating and radiological tumor biomarkers, potentially useful at every stage of diagnosis and prognostic or theranostic evaluation.
Detailed description
The aim is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the health centers, patients were identified in two ways: 1. via diagnoses obtained in the anatomopathology departments of each investigating center 2. via multidisciplinary consultation meetings on primary hepatic tumours/digestive oncology at each investigating center. Patients with a diagnosis of rare primary hepatic cancers diagnosed on or after 01/01/2018 may be included, whether alive or deceased at the time of registration in the CAPRIH cohort.
Key inclusion criteria (4 listed)
- 18 years of age or older,
- with histologically proven hepato-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma or hepatic angiosarcoma
- diagnosed after January 01, 2018 living or deceased at the time of registration in the cohort
- for living patients who have not objected to the research: (note of non-objection to be attached° agreeing to participate in ancillary studies must sign the biological consent form for participation in biological studies.
Key exclusion criteria (2 listed)
- without social security
- No access to tumor block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the clinical, histological and radiological characteristics of various rare primary liver cancers
Time frame: up to 5 years from the date of diagnosis
Description of the clinical, histological and radiological characteristics of various rare primary liver cancers
3 secondary outcomes
Recurrence-free survival (for non-metastatic patients)
Time frame: up to 5 years from diagnosis
Progression-free survival (for metastatic patients)
Time frame: up to 5 years from diagnosis
Overall survival
Time frame: up to 5 years from diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Hepatocholangiocarcinoma
Not yet recruitingPhase 2
A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
Combined Hepatocellular and Cholangiocarcinoma
Active, not recruitingPhase 2
A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer
Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Stage III Liver Cancer
Active, not recruitingObservational study
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
Hepatocellular Carcinoma, Hepatocellular Cancer
RecruitingPhase 2
HAIC Combined With Camrelizumab Plus Rivoceranib for Advanced Mixed Hepatocellular-cholangiocarcinoma (HCC-CCA)
Mixed Hepatocellular-cholangiocarcinoma
RecruitingObservational study
Novel Subtypes and Treatment Strategies of Patients with Unresectable Combined Hepatocellular Cholangiocarcinoma Based on Multimodal Data
Combined Hepatocellular-cholangiocarcinoma, Combined Hepatocellular Carcinoma and Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
jean-charles nault, Pr principal investigator
Federation Francophone de Cancerologie Digestive
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocholangiocarcinoma and Fibrolamellar Carcinoma, run by Federation Francophone de Cancerologie Digestive at 40 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lila gaba (06 99 78 84 73, lila.gaba@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the clinical, histological and radiological characteristics of various rare primary liver cancers (time frame: up to 5 years from the date of diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.