Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting now · Phase 3

Conditions studied: Biliary Tract Neoplasms

In brief

The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

Key facts

Study ID

NCT05615818

Run by

UNICANCER

People needed

800

Starts

2024-07-18

Expected to finish

2028-06-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed a written informed consent form prior to any trial specific procedures (Consent #1)
• Histologically-proven intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded)
• De novo or recurrent, locally advanced (non-resectable) or metastatic disease
• 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
• Aged ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Estimated life expectancy >3 months
• Candidate for 1L-SoC therapy, or has initiated first cycle of 1L-SoC therapy
• Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements).

You may not qualify if…

• Contraindication to 1L-SoC
• Patients who are candidates for locoregional therapy
• Contraindication to tumour biopsy in the absence of suitable archived sample of tumour tissue
• Prior anticancer therapy in the palliative setting. Adjuvant capecitabine allowed if completed ≥ 183 days prior to study entry
• Received more than 1 cycle of treatment with 1L-SoC
• Prior treatment with any of the MTT under investigation in the SAFIR-ABC10 study
• 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
• 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
• Women who are pregnant or breast-feeding
• Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
• Individuals deprived of liberty or placed under protective custody or guardianship
• RANDOMISED TRIAL
• Inclusion Criteria:
• Signed a written informed consent form prior to any trial specific procedures (Consent #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)
• Disease control (stable or responsive) after 4 cycles of 1L-SoC, compared to a pre-treatment disease evaluation, as assessed by the investigator
• ECOG performance status of 0 or 1
• Presence of at least one evaluable lesion according to RECIST v1.1, or complete response to 12 weeks 1L-SoC
• Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, and haemoglobin ≥9 g/dL
• 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)
• Adequate renal function: estimated creatinine clearance ≥ 60 mL/min according to the Cockcroft-Gault formula
• Adequate cardiac function: left ventricular ejection fraction ≥50% at baseline as determined by either echocardiogram or multigated acquisition scan (MUGA)
• Adequate biliary drainage, with no evidence of ongoing infection
• 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.
• Women of childbearing potential must have a negative serum pregnancy test performed within 3 days before the date of randomisation

Where it is running

• APHP - Hôpital Saint Antoine — Paris, France (enrolling)
• CH de Pau — Pau, France (enrolling)
• Institut de Cancer de Montpellier — Montpellier, France (enrolling)
• APHP - Hôpital Cochin — Paris, France (enrolling)
• Institute Mutualiste Montsouris — Paris, France (enrolling)
• Institut de cancerologie de l'Ouest - Angers — Angers, France (enrolling)
• Institut Paoli Calmettes — Marseille, France (enrolling)
• CHU de Besançon — Besançon, France (enrolling)
• Centre Antoine Lacassagne — Nice, France (enrolling)
• APHP - Hôpital Beaujon — Paris, France (enrolling)
• CHU d'Angers — Angers, France (enrolling)
• CHU Estaing de Clermont Ferrand — Clermont-Ferrand, France (enrolling)
• APHP - Hopital Henri Mondor — Créteil, France (enrolling)
• CHU de Dijon — Dijon, France (enrolling)
• Institut du Cancer Avignon Provence — Avignon, France (enrolling)
• Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard — Grenoble, France (enrolling)
• Centre Oscar Lambret — Lille, France (enrolling)
• CHU Lille — Lille, France (enrolling)
• CHU Dupuytren — Limoges, France (enrolling)
• CHU Amiens Picardie — Amiens, France (enrolling)
• Centre François Baclesse — Caen, France (enrolling)
• Hospices Civils de Lyon - Croix Rousse — Lyon, France (enrolling)
• Centre Jean Perrin — Clermont-Ferrand, France (enrolling)
• Hôpital Européen — Marseille, France (enrolling)
• CHU Poitiers — Poitiers, France (enrolling)

Full record on ClinicalTrials.gov

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