Personalized Medicine for Advanced Biliary Cancer Patients

Sponsor
UNICANCER
Study ID
NCT05615818
Phase
PHASE3
Status
Recruiting
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Conditions

  • Biliary Tract Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Futibatinib — DRUG
    Dose 20 mg once a day (QD)
  • Ivosidenib — DRUG
    Dose 500 mg QD
  • Zanidatamab — DRUG
    Dose: Patients \< 70 kg: 1800 mg every 3 weeks (Q3W), Patients ≥ 70 kg: 2400 mg Q3W
  • Trastuzumab — DRUG
    Loading dose 8 mg/kg, then 6 mg/kg Q3W (Combination with neratinib)
  • Neratinib — DRUG
    Dose: 240 mg QD (combination with trastuzumab)
  • Encorafenib — DRUG
    Dose: 450 mg QD (Combination with binimetinib)
  • Binimetinib — DRUG
    Dose: 45 mg twice a day (BID) (Combination with encorafenib)
  • Niraparib — DRUG
    Dose: 200 mg QD or 300 mg QD
  • Cisplatin — DRUG
    Dose: 25 mg/m2 IV on days 1 and 8 Q3W (CISGEM)
  • Gemcitabine — DRUG
    Dose: 1000 mg/m2 IV on days 1 and 8 Q3W (CISGEM)

Study Details

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 Dates

Start date
Jul 18, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Molecular targeted therapy matched to genetic alteration carried by the tumour
  • Active Comparator: Control
    Continued standard of care treatment for first-line biliary tract cancer

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From randomisation to disease progression or death, up to 5 years. ]

Central Contacts

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