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DISEASE & TREATMENT SETTING

Malignant Biliary Tract Neoplasm

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

Malignant Biliary Tract Neoplasm

Source population
Not part of this definition
Disease extent
Not part of this definition
Treatment line
Not part of this definition
Stage
Not part of this definition
Resectability
Not part of this definition
Biomarkers, prior therapy and derivation
molecular
    prior therapy
      derivation status
      source-attested
      derivation note
      Added because the terminology and the registry both attest it: an NCIt neoplasm concept named by 7 acquired study condition(s). It is absent from the NCI treatment-topic directory, which is not an exhaustive cancer inventory.
      source wording
      Source null
      4 more-specific settings
      Ziihera: unresectable metastatic Biliary tract cancer with HER2 positive →KEYTRUDA: unresectable metastatic Biliary tract cancer →KEYTRUDA QLEX: unresectable metastatic Biliary tract cancer →IMFINZI: metastatic Biliary tract cancer →

      Study evidence for this setting

      8 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

      NCT02443324 · Registry condition search · Scope: narrower

      A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

      6 outcome links · 7 safety-group records · 0 quality-of-life measures

      →

      NCT02489422 · Registry condition search · Scope: narrower

      Programs To Support You During Chemotherapy

      6 outcome links · 2 safety-group records · 14 quality-of-life measures

      →

      NCT03797326 · Registry condition search · Scope: narrower

      Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

      6 outcome links · 8 safety-group records · 0 quality-of-life measures

      →

      NCT03875235 · Source cited / selected · Scope: narrower

      Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

      6 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT04003636 · Source cited / selected · Scope: narrower

      Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/

      6 outcome links · 3 safety-group records · 0 quality-of-life measures

      →

      NCT04234113 · Registry condition search · Scope: narrower

      Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors

      6 outcome links · 17 safety-group records · 0 quality-of-life measures

      →

      NCT04579380 · Source cited / selected · Scope: narrower

      Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

      6 outcome links · 9 safety-group records · 0 quality-of-life measures

      →

      NCT05012397 · Registry condition search · Scope: narrower

      Milademetan in Advanced/Metastatic Solid Tumors

      5 outcome links · 1 safety-group records · 0 quality-of-life measures

      →

      Indication-specific source history

      Dated source events, not confirmation of current approval for every use of a drug.

      2024-11-20 · Ziihera (zanidatamab-hrii) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-malignant-biliary-tract-neoplasm
      event id
      fda-2aa62ee68890907d
      event date
      2024-11-20
      event kind
      accelerated-approval
      drug or regimen
      Ziihera (zanidatamab-hrii)
      source indication text
      Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test
      match phrase
      biliary tract cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-e7f3c059d664475c015b
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      Source relationships and population-mapping limitations
      bindings
      1. release id
        clinical-indications-draft-1
        disease state id
        ds-malignant-biliary-tract-neoplasm
        binding id
        ncit-C227648
        source collection
        ncit-concept
        source key
        C227648
        source excerpt
        Source null
        match status
        exact
        match note
        Source null
        recorded at
        2026-09-10T00:00:00Z
      mappings

        Download this complete draft source relationship record →

        Preserved source evidence · Not medical advice