Personalized Medicine for Advanced Biliary Cancer Patients

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Futibatinib
  • Ivosidenib
  • Zanidatamab
  • Trastuzumab
  • Neratinib
  • Encorafenib
  • Binimetinib
  • Niraparib
  • Cisplatin
  • Gemcitabine

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators

UNICANCER

Lead sponsor

Cancer Research UK & UCL Cancer Trials Centre

Collaborator

Belgian Group of Digestive Oncology

Collaborator

National Cancer Institute, France

Collaborator

Cancer Research UK

Collaborator

Taiho Oncology, Inc.

Collaborator

Servier

Collaborator

Zymeworks BC Inc.

Collaborator

Accord Healthcare, Inc.

Collaborator

Pierre Fabre Medicament

Collaborator