OncoMatch/Clinical Trials/NCT05615818
Personalized Medicine for Advanced Biliary Cancer Patients
Is NCT05615818 recruiting? Yes, currently enrolling (May 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
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.
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