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Baseline organ dysfunction precluding standard gemcitabine + cisplatin + durvalumab in ad...

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IDRF-CHOLANGIOCARCINOMA-ORGAN-DYSFUNCTION
TypeSignal d’alerte
Étatreviewed 2026-04-27 | pending_clinical_signoff
MaladiesDIS-CHOLANGIOCARCINOMA
SourcesSRC-ESMO-BTC-2023 SRC-NCCN-HEPATOBILIARY

Origine du drapeau rouge

DéfinitionBaseline organ dysfunction precluding standard gemcitabine + cisplatin + durvalumab in advanced biliary tract cancer: Child-Pugh B/C cirrhosis or bilirubin >3× ULN (impaired hepatic clearance of gem-cis + FGFR2/IDH1 inhibitors, increased toxicity), CrCl <30 mL/min (cisplatin contraindicated; reduced gemcitabine), or LVEF <50% (FGFR2-inhibitor cardiac monitoring requirement).
Direction cliniquedésescalade
Catégoriedysfonction d'organe

Logique de déclenchement

{
  "any_of": [
    {
      "finding": "child_pugh_class",
      "value": "B"
    },
    {
      "finding": "child_pugh_class",
      "value": "C"
    },
    {
      "comparator": ">=",
      "finding": "bilirubin_ratio_to_uln",
      "threshold": 3
    },
    {
      "comparator": "<",
      "finding": "creatinine_clearance_ml_min",
      "threshold": 30
    },
    {
      "comparator": "<",
      "finding": "lvef_percent",
      "threshold": 50
    }
  ],
  "type": "lab_value"
}

Notes

Child-Pugh B/C: cisplatin component should be omitted or replaced; consider gemcitabine monotherapy or capecitabine. FGFR2-inhibitors (pemigatinib, futibatinib, infigratinib) require dose adjustment in hepatic impairment per FDA labels. Ivosidenib (IDH1) requires QTc monitoring + dose reduction with hepatic dysfunction. CrCl <30: cisplatin contraindicated — substitute carboplatin or omit. ABC-02 / TOPAZ-1 / KEYNOTE-966 enrolled mostly preserved hepatic function; extrapolation to Child-Pugh B requires individualized risk-benefit.

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