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Biliary Tract CancerNCT04935853

Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study

An observational study of Biliary Tract Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 32 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. The effectiveness and tolerance of these treatments in current practice will also be evaluated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
How many people
1,350 participants
Where
32 sitesFrance
Study dates
23 May 2022to 1 Jun 2040
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: Retro-prospective (diagnosis between 2003 and 2020) and prospective (diagnosis between 2021 and 2030) cohorts of patients with Bile Duct Cancer

Who may be able to join

  • All locations of primitives (intrahepatic CCA, extrahepatic CCA, adenocarcinoma of the gallbladder; ampullomas excluded)
  • Age > 18 years
  • Diagnosed between 2003 and 2030 (minimum follow-up 2 years)
  • Written written non-opposition +/- signed informed consent for genetic studies (N.B.:
  • exemption requested for a deceased patient) N.B. Authorized inclusion in a therapeutic research protocol

Who cannot join

  • Patient under guardianship, curatorship or legal protection
  • Pregnant or breastfeeding women
  • Any medical, psychological or social situation, which could prevent the compliance with the protocol according to the investigator's assessment
  • Refusal to participate in the study

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cindy Neuzillet, Dr contact

+33 (0)1 47 11 15 15

cindy.neuzillet@curie.fr

Marie-Line Garcia, Dr contact

+33 (0)1 40 29 85 00

marie-line.garcia-larnicol@gercor.com.fr

32 sites in 1 country

France32 sites, 32 recruiting

  • CHU Hôpital Sud Amiens

    Amiens

    Vincent HAUTEFEUILLE, MD

    Recruiting

  • CHU Angers

    Angers

    Carole VITELLIUS, MD

    Recruiting

  • CHU Besançon

    Besançon

    Angélique VIENOT, MD

    Recruiting

  • Hôpital Avicenne

    Bobigny

    Jean Charles NAULT, MD

    Recruiting

  • CHU - Henri Mondor

    Créteil

    Christophe TOURNIGAND, MD

    Recruiting

  • CHU Dijon

    Dijon

    Sylvain MANFREDI, MD

    Recruiting

  • CHU Grenoble

    Grenoble

    Gaël ROTH, MD

    Recruiting

  • CHU Lille

    Lille

    Anthony TURPIN, MD

    Recruiting

  • Centre Léon Bérard

    Lyon

    Mathieu SARABI, MD

    Recruiting

  • Hôpital Croix Rousse

    Lyon

    Marielle GUILLET, MD

    Recruiting

  • Hôpital Edouard Herriot

    Lyon

    Thomas WALTER, MD

    Recruiting

  • Hôpital Privé Jean Mermoz

    Lyon

    Pascal ARTRU, MD

    Recruiting

  • Institut Paoli Calmette

    Marseille

    Brice CHANEZ, MD

    Recruiting

  • CHU Saint Eloi Montpellier

    Montpellier

    Eric ASSENAT, MD

    Recruiting

  • CHR Orléans

    Orléans

    Jean Paul LAGASSE, MD

    Recruiting

  • Groupe Hospitalier Pitié Salpêtrière

    Paris

    Jean Baptiste BACHET, MD

    Recruiting

  • Hôpital Ambroise Paré

    Paris

    Aude GUILLEMIN, MD

    Recruiting

  • Hôpital Cochin

    Paris

    Romain CORIAT, MD

    Recruiting

  • Hôpital Saint Antoine

    Paris

    Raphaël COLLE, MD

    Recruiting

  • Hôpital Saint Louis

    Paris

    Nelson LOURENCO, MD

    Recruiting

  • Institut Mutualiste Montsouris

    Paris

    Christophe LOUVET, MD

    Recruiting

  • Hôpital Haut Lévêque

    Pessac

    Jean François BLANC, MD

    Recruiting

  • CHU Poitiers

    Potiers

    David TOUGERON, MD

    Recruiting

  • Hôpital Robert Debré -CHU Reims

    Reims

    Alexandra HEURGUE, MD

    Recruiting

  • Centre Eugène Marquis

    Rennes

    Julien EDELINE, MD

    Recruiting

  • CHU Rouen Charles Nicolle

    Rouen

    Lilian SCHWARZ, MD

    Recruiting

  • Institut Curie

    Saint-Cloud

    Cindy NEUZILLET, MD

    Recruiting

  • CHU Saint Etienne

    Saint-Etienne

    Nicolas WILLET, MD

    Recruiting

  • CHU Rangueil

    Toulouse

    Nadim FARES, MD

    Recruiting

  • CHU Tours

    Tours

    Thierry LECOMTE, MD

    Recruiting

  • CHRU Nancy Site Brabois

    Vandœuvre-lès-Nancy

    Marie MULLER, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Antoine HOLLEBECQUE, MD

    Recruiting

Other trials in France

About this study

Official title: Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL

The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. The effectiveness and tolerance of these treatments in current practice will also be evaluated.

Read the detailed description

Bile duct cancers are a heterogeneous group of rare tumors with a poor prognosis. Surgery is the only curative modality for localized forms. Chemotherapy is the standard treatment in advanced forms. Identification of prognostic and predictive markers to better stratify patients and to guide therapeutic decisions is a major issue. It is retro-prospective (diagnosis between 2003 and 2021) and prospective (diagnosis between 2021 and 2030) multi-center, cohort study. Follow-up for 10 years from initial cancer diagnosis will be done.

Follow-up is retrospective only for patients operated on or diagnosed in the past for more than 10 years, and retro-prospective for operated patients or diagnosed in the past for less than 10 years.

The data collected for each patient are available during the life cycle of this clinical trial to fulfil an educational requirement (e.g. a doctoral thesis) upon request and authorization from the study committee and the study sponsor (GERCOR).

Keywords
predictive, prognostic, biliary track cancer
Medical subject headings
Biliary Tract Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months

    Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with advanced bile duct cancer (BDC).

    OS defined as a period between the start of treatment and death, whatever the cause.

    Measured: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)

Secondary outcomes (7)

  1. Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months

    Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with bile localized BDC (operated).

    OS defined as a period between the start of treatment and death, whatever the cause.

    Measured: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)

  2. Response rate

    Assessment of treatments effects on the response rate (RECIST v 1.1, Choi).

    Measured: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)

  3. Effect of treatments on secondary resection rate R0 of the primary tumor

    Assessment of treatments on secondary resection rate R0 of the primary tumor

    Measured: From day of surgical intervention until 30 days

  4. Effects of treatments on disease-free survival (DFS)

    Assessment of treatments effects on disease-free survival (DFS) in patients who underwent surgery.

    Measured: Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause

  5. Effects of treatments on progression-free survival (PFS)

    Assessment of treatments effects on progression-free survival (PFS) in non-operated patients

    Measured: Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause

  6. Toxicities (Adverse events) experienced by patients

    Evaluation of toxicity assessed by CTCAE v 5.0

    Measured: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)

  7. The complications and postoperative mortality rates in patients who underwent surgery

    Assessment of the complications rate (Clavien classification) and of postoperative mortality in patients who underwent surgery

    Measured: From day of surgical intervention until 30 days; up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start23 May 2022
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2040 (estimated)

Resources

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
1,350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04935853
Sponsor's protocol ID
ACABi PRONOBIL GB-115
Status last verified
Jul 2025
First submitted
28 May 2021
Last updated
23 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Noe C, Henriques J, Chanez B, Vernerey D, Lecomte T, Durand A, Assenat E, Edeline J, Heurgue A, Tougeron D, Manfredi S, Hautefeuille V, Neuzillet C, Roth G, Lagasse JP, Tournigand C, Delaye M, Hollebecque A, Turpin A, Parent P. Adjuvant capecitabine in resected biliary tract cancer: a real-world data from the BILCAP-Real study (ACABi multicentre cohort). JHEP Rep. 2026 Jul 28:101968. doi: 10.1016/j.jhepr.2026.101968. Online ahead of print.

    PubMed 42520930

  • Adamus N, Edeline J, Henriques J, Fares N, Lecomte T, Turpin A, Vernerey D, Vincens M, Chanez B, Tougeron D, Tournigand C, Assenat E, Delaye M, Manfredi S, Bouche O, Williet N, Vienot A, Blaise L, Mas L, Neuzillet C, Boileve A, Roth GS. First-line chemotherapy with selective internal radiation therapy for intrahepatic cholangiocarcinoma: The French ACABi GERCOR PRONOBIL cohort. JHEP Rep. 2024 Nov 20;7(2):101279. doi: 10.1016/j.jhepr.2024.101279. eCollection 2025 Feb.

    PubMed 39897613

Questions about this trial

What is this clinical trial studying?

An observational study of Biliary Tract Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 32 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 5 inclusion and 4 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 Cindy Neuzillet, Dr (+33 (0)1 47 11 15 15, cindy.neuzillet@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months (time frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04935853, which also lists 2 linked publications.

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 23 Jul 2025.

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