OncoMatch/Clinical Trials/NCT05615818
Personalized Medicine for Advanced Biliary Cancer Patients
Is NCT05615818 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for biliary tract neoplasms.
Treatment: Futibatinib · Ivosidenib · Zanidatamab · Trastuzumab · Neratinib · Encorafenib · Binimetinib · Niraparib · Cisplatin · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: first-line standard of care — advanced/palliative
Candidate for 1L-SoC therapy, or has initiated first cycle of 1L-SoC therapy
Cannot have received: anticancer therapy in the palliative setting
Exception: Adjuvant capecitabine allowed if completed ≥ 183 days prior to study entry
Prior anticancer therapy in the palliative setting. Adjuvant capecitabine allowed if completed ≥ 183 days prior to study entry
Cannot have received: molecularly targeted therapy under investigation in the SAFIR-ABC10 study
Prior treatment with any of the MTT under investigation in the SAFIR-ABC10 study
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, haemoglobin ≥9 g/dL
Kidney function
estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
Liver function
total bilirubin ≤1.5 × ULN (≤3.0 ULN with Gilbert syndrome); AST/ALT ≤2.5 × ULN (≤5 × ULN with tumour liver involvement)
Cardiac function
left ventricular ejection fraction ≥50% at baseline (by echocardiogram or MUGA)
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 × ULN (≤3.0 ULN with Gilbert syndrome), AST and ALT ≤2.5 × ULN (≤5 ULN with tumour liver involvement); Adequate renal function: estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault); Adequate cardiac function: left ventricular ejection fraction ≥50% at baseline (by echocardiogram or MUGA)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05615818 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anticancer therapy in the palliative setting, molecularly targeted therapy under investigation in the SAFIR-ABC10 study disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify