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
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