Personalized cancer care: new trial aims to improve outcomes in biliary cancer

NCT ID NCT05615818

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether giving a targeted therapy after initial standard chemotherapy can help people with advanced biliary cancer live longer without their disease getting worse. Participants must have a tumor with a specific genetic change and stable disease after four cycles of chemo. They will be randomly assigned to receive either a matched targeted drug or continue standard care. The study aims to enroll 800 people across multiple countries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Futibatinib, Ivosidenib, Zanidatamab, Trastuzumab, Neratinib, Encorafenib, Binimetinib
What this could lead to: If successful, this could offer a more effective, personalized maintenance treatment option for people with advanced biliary cancer whose tumors have specific genetic changes.
What could go wrong: This is a large phase 3 trial, but it only includes patients whose tumors have certain genetic markers, which may limit who can benefit. The targeted therapies also have their own side effects and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

SCREENING PHASE Inclusion Criteria: 1. Signed a written informed consent form prior to any trial specific procedures (Consent #1) 2. Histologically-proven intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded) 3. De novo or recurrent, locally advanced (non-resectable) or metastatic disease 4. Availability of a suitable archived sample of primary or metastatic tumour tissue (frozen, or FFPE) or able to undergo a biopsy to obtain a suitable malignant tissue sample 5. Aged ≥18 years 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Estimated life expectancy \>3 months 8. Candidate for 1L-SoC therapy, or has initiated first cycle of 1L-SoC therapy 9. Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements). Exclusion Criteria: 1. Contraindication to 1L-SoC 2. Patients who are candidates for locoregional therapy 3. Contraindication to tumour biopsy in the absence of suitable archived sample of tumour tissue 4. Prior anticancer therapy in the palliative setting. Adjuvant capecitabine allowed if completed ≥ 183 days prior to study entry 5. Received more than 1 cycle of treatment with 1L-SoC 6. Prior treatment with any of the MTT under investigation in the SAFIR-ABC10 study 7. Current malignancies (other than ABC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial 8. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol 9. Women who are pregnant or breast-feeding 10. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons 11. Individuals deprived of liberty or placed under protective custody or guardianship RANDOMISED TRIAL Inclusion Criteria: 1. Signed a written informed consent form prior to any trial specific procedures (Consent #2) 2. Molecular profile showing the tumour harbours at least one targetable molecular alteration with a MTT in the study portfolio (as determined by the trial MTB) 3. Disease control (stable or responsive) after 4 cycles of 1L-SoC, compared to a pre-treatment disease evaluation, as assessed by the investigator 4. ECOG performance status of 0 or 1 5. Presence of at least one evaluable lesion according to RECIST v1.1, or complete response to 12 weeks 1L-SoC 6. Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, and haemoglobin ≥9 g/dL 7. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (total bilirubin ≤3.0 ULN when the patient has documented Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 ULN when documented tumour liver involvement) 8. Adequate renal function: estimated creatinine clearance ≥ 60 mL/min according to the Cockcroft-Gault formula 9. Adequate cardiac function: left ventricular ejection fraction ≥50% at baseline as determined by either echocardiogram or multigated acquisition scan (MUGA) 10. Adequate biliary drainage, with no evidence of ongoing infection 11. Men, and women of childbearing potential (WOCBP) must agree to use adequate contraception for the duration of trial participation and as required after completing study treatment. Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period. 12. Women of childbearing potential must have a negative serum pregnancy test performed within 3 days before the date of randomisation 13. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures 14. Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements) Exclusion Criteria: 1. Disease progression occurring at any time prior randomisation, or toxicity that led to the discontinuation of the 1L-SoC before 4 full cycles have been delivered 2. Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 the National Cancer Institute - Common terminology criteria for adverse events \[NCI-CTCAE v5.0\]) before randomisation, with the exception of alopecia 3. Contraindication or known hypersensitivity to the MTT for the molecular alteration found in the patient, or any component in their formulation Note: For patients with multiple target alterations, contraindication to one MTT will not warrant exclusion if MTT to an alternative target is feasible. 4. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers 5. Major surgery within 4 weeks of randomisation 6. Radiotherapy within 7 days of randomisation 7. Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening). 8. Clinically significant cardiovascular disease (recent acute myocardial infarction, treated congestive heart failure \[2 or above on the New York Heart Association functional classification scale\], recent thromboembolic or cerebrovascular events \[within 12 weeks, excepted if related to indwelling catheter\], known prolonged QT syndrome). 9. Cardiorespiratory pathologies where hyperhydration is contraindicated. 10. Manifestation of tinnitus and/or hearing loss since initiation of cisplatin therapy. 11. Known leptomeningeal disease. If leptomeningeal disease has been reported radiographically on baseline magnetic responance imaging (MRI), but is not suspected clinically by the investigator, the subject must be free of neurological symptoms. 12. Concurrent malignancy (other than ABC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial 13. Concomitant treatment with phenytoin in prophylactic use where this cannot be substituted for another therapy 14. Known active hepatitis B virus or hepatitis C virus infection or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome 15. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol 16. Women who are pregnant or breast-feeding 17. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable 18. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons 19. Individuals deprived of liberty or placed under protective custody or guardianship ADDITIONAL EXCLUSION CRITERIA FOR SPECIFIC MTTs: Patients assigned to receive oral therapies: 1. Inability or unwillingness to swallow pills 2. History of malabsorption syndrome or other condition that would interfere with enteral absorption. For example, active intestine inflammation (e.g., Crohn's disease or ulcerative colitis) requiring immunosuppressive therapy Futibatinib: 1. History and/or current evidence of any of the following disorders: 1. Non-tumour related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator 2. Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator 3. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator 2. Concomitant treatment with strong CYP3A/P-gp inhibitors or strong or moderate CYP3A/P gp inducers where these cannot be substituted for another therapy. Ivosidenib: 1. Patients with history of torsade de pointes 2. Concomitant treatment with digoxin where this cannot be substituted for another therapy 3. Patients with a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec or other factors that increased the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT interval syndrome) 4. Concomitant treatment with strong CYP3A4 inducers or dabigatran where these cannot be substituted for another therapy 5. Concomitant treatment with medicinal products known to prolong the QTc interval, or moderate or strong CYP3A4 inhibitors where these cannot be substituted for another therapy 6. Familial history of sudden death or polymorphic ventricular arrhythmia. 7. Hypokalemia, hypomagnesemia or hypocalcemia where this cannot be corrected by supplementation Zanidatamab: 1. Treatment with anthracyclines within 90 days before first dose of zanidatamab and/or total lifetime load exceeding 360 mg/m2 Adriamycin® or equivalent 2. Use of corticosteroids administered at doses equivalent to \> 15 mg per day of prednisone within 2 weeks of first zanidatamab dosing unless otherwise approved by the coordinating investigator. Topical, ocular, intra-articular, intranasal, and/or inhalational corticosteroids are permitted 3. QTcF \> 470 ms 4. History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure 5. Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease 6. Clinically significant infiltrative pulmonary disease not related to lung metastases 7. A history of life-threatening hypersensitivity to monoclonal antibodies or recombinant proteins Neratinib \& trastuzumab: 1. Patients with severe hepatic impairment (Child-Pugh Class C) 2. Co-administration with the following medical products that are strong inducers of the CYP3A4/P-gp isoform of cytochrome P450, such as carbamazepine, phenytoin (antiepileptics), St John's wort (Hypericum perforatum) or rifampicin (antimycobacterial) 3. Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy or co-morbidities 4. Hypersensitivity to murine proteins 5. Current active pneumonitis within 90 days of receiving trastuzumab or a known history of interstitial lung disease Encorafenib \& binimetinib: 1. Patients with a history or current evidence of retinal vein occlusion or risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or history of hyperviscosity or hypercoagulability syndrome) 2. Patients with concurrent neuromuscular disorders associated with elevated creatine phosphokinase (\>ULN) 3. Patients with hypokalemia, hypomagnesemia, or hypocalcemia (i.e. Serum potassium, magnesium or calcium \< lower normal limit) 4. Patients with a QTcF ≥ 450 msec for men, or ≥ 470 msec for women 5. Current or expected use of a strong inhibitor of CYP3A4

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Conditions

The condition(s) this trial relates to.

biliary tract cancer biliary tract neoplasm Biliary Tract Neoplasms distal biliary tract carcinoma gallbladder carcinoma intrahepatic cholangiocarcinoma perihilar intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

69 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

APHM - CHU La Timone
NOT_YET_RECRUITING

Marseille, France
APHP - Hopital Henri Mondor
RECRUITING

Créteil, France
APHP - Hôpital Beaujon
RECRUITING

Paris, France
APHP - Hôpital Cochin
RECRUITING

Paris, France
APHP - Hôpital Paul Brousse
NOT_YET_RECRUITING

Villejuif, France
APHP - Hôpital Saint Antoine
RECRUITING

Paris, France
Addenbrooke's Hospital
NOT_YET_RECRUITING

Cambridge, United Kingdom
Bristol Haematology and Oncology Centre
RECRUITING

Bristol, United Kingdom
CH Cornouaille
RECRUITING

Quimper, France
CH Valence
RECRUITING

Valence, France
CH de Pau
RECRUITING

Pau, France
CHRU de Nancy
RECRUITING

Vandœuvre-lès-Nancy, France
CHU Amiens Picardie
RECRUITING

Amiens, France
CHU Charles Nicolle
NOT_YET_RECRUITING

Rouen, France
CHU Dupuytren
RECRUITING

Limoges, France
CHU Estaing de Clermont Ferrand
RECRUITING

Clermont-Ferrand, France
CHU Grenoble Alpes
NOT_YET_RECRUITING

Grenoble, France
CHU Lille
RECRUITING

Lille, France
CHU Nantes - Hôtel Dieu
NOT_YET_RECRUITING

Nantes, France
CHU Poitiers
RECRUITING

Poitiers, France
CHU Toulouse
RECRUITING

Toulouse, France
CHU d'Angers
RECRUITING

Angers, France
CHU de Besançon
RECRUITING

Besançon, France
CHU de Bordeaux - Hôpital Haut-Leveque
NOT_YET_RECRUITING

Bordeaux, France
CHU de Dijon
RECRUITING

Dijon, France
CHU de Reims
RECRUITING

Reims, France
Castle Hill Hospital
NOT_YET_RECRUITING

Cottingham, United Kingdom
Centre Antoine Lacassagne
RECRUITING

Nice, France
Centre Eugène Marquis
RECRUITING

Rennes, France
Centre François Baclesse
RECRUITING

Caen, France
Centre Jean Perrin
RECRUITING

Clermont-Ferrand, France
Centre Leon Bérard
NOT_YET_RECRUITING

Lyon, France
Centre Oscar Lambret
RECRUITING

Lille, France
Churchill Hospital
NOT_YET_RECRUITING

Oxford, United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust
NOT_YET_RECRUITING

Liverpool, United Kingdom
Clinique Privée Jean Mermoz
NOT_YET_RECRUITING

Lyon, France
Cliniques universitaires Saint-Luc
NOT_YET_RECRUITING

Brussels, Belgium
Cliniques universitaires de Bruxelles - Hôpital Erasme ULB
NOT_YET_RECRUITING

Brussels, Belgium
Groupe Hospitalier Diaconesses Croix Saint-Simon
NOT_YET_RECRUITING

Paris, France
Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard
RECRUITING

Grenoble, France
Gustave Roussy
RECRUITING

Villejuif, France
Guy's & St Thomas' Hospital
NOT_YET_RECRUITING

London, United Kingdom
Hammersmith Hospital
RECRUITING

London, United Kingdom
Hospices Civils de Lyon - Croix Rousse
RECRUITING

Lyon, France
Hôpital Européen
RECRUITING

Marseille, France
Hôpital Foch
RECRUITING

Suresnes, France
Institut Curie - Saint Cloud
NOT_YET_RECRUITING

Saint-Cloud, France
Institut Jean Godinot
RECRUITING

Reims, France
Institut Paoli Calmettes
RECRUITING

Marseille, France
Institut de Cancer de Montpellier
RECRUITING

Montpellier, France
Institut de Cancerologie de l'Ouest
NOT_YET_RECRUITING

Saint-Herblain, France
Institut de cancerologie de l'Ouest - Angers
RECRUITING

Angers, France
Institut du Cancer Avignon Provence
RECRUITING

Avignon, France
Institute Mutualiste Montsouris
RECRUITING

Paris, France
Maidstone Hospital
NOT_YET_RECRUITING

Maidstone, United Kingdom
Mount Vernon Cancer Centre
RECRUITING

Northwood, United Kingdom
North West Anglia NHS Foundation Trust
NOT_YET_RECRUITING

Peterborough, United Kingdom
Nottingham University Hospital
RECRUITING

Nottingham, United Kingdom
Queen Elizabeth Hospital
RECRUITING

Birmingham, United Kingdom
Royal Free Hospital
NOT_YET_RECRUITING

London, United Kingdom
Royal Marsden Hospital
RECRUITING

London, United Kingdom
Singleton Hospital
NOT_YET_RECRUITING

Swansea, United Kingdom
Southampton General Hospital
NOT_YET_RECRUITING

Southampton, United Kingdom
St James's Hospital
NOT_YET_RECRUITING

Leeds, United Kingdom
The Christie Hospital
NOT_YET_RECRUITING

Manchester, United Kingdom
Universitair Ziekenhuis Antwerpen (UZA)
NOT_YET_RECRUITING

Edegem, Belgium
Universitair Ziekenhuis Leuven
NOT_YET_RECRUITING

Leuven, Belgium
University College London
RECRUITING

London, United Kingdom
Weston Park Cancer Centre
NOT_YET_RECRUITING

Sheffield, United Kingdom

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