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    CANCER:

    Biliary Tract Cancer

    Related cancers:
    2d
    Real-World Outcomes of Ivosidenib in IDH1-Mutant Biliary Tract Cancer: A Multicenter Retrospective Analysis and Comparison with the TrinetX Database. (PubMed, Target Oncol)
    Real-world data from our cohort and the TriNetX database support the oncological outcomes reported in the ClarIDHy trial and other real-world cohorts.
    Retrospective data • Journal • Real-world evidence
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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    IDH1 mutation • IDH1 R132
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    Tibsovo (ivosidenib)
    4d
    Efficacy and safety of immune checkpoint inhibitors in patients with high microsatellite instability/mismatch repair-deficient advanced cholangiocarcinoma: A propensity score-matched study. (PubMed, JHEP Rep)
    In this real-world PSM study, MSI-H/dMMR CCA was associated with markedly improved survival and durable clinical benefit from ICI-based therapy, with a manageable safety profile. These findings support MSI-H/dMMR as a key actionable biomarker and underscore the importance of routine MSI testing in CCA.
    Journal • Checkpoint inhibition • Mismatch repair • Microsatellite instability • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • MSI-H • dMMR
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    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • ARID1A (AT-rich interaction domain 1A) • PBRM1 (Polybromo 1) • KMT2D (Lysine Methyltransferase 2D) • CA 19-9 (Cancer antigen 19-9)
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    PD-L1 expression • MSI-H/dMMR
    7d
    Phase II Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Sun Yat-sen University
    New P2 trial
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    Lenvima (lenvatinib) • albumin-bound paclitaxel • Qibeian (iparomlimab/tuvonralimab)
    13d
    DESTINY-PanTumor02: A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (clinicaltrials.gov)
    P2, N=477, Active, not recruiting, AstraZeneca | Trial completion date: Jul 2027 --> Mar 2027 | Trial primary completion date: Jul 2027 --> Mar 2027
    Trial completion date • Trial primary completion date • Pan tumor
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    HER-2 expression
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    Enhertu (fam-trastuzumab deruxtecan-nxki)
    13d
    Beacon-BTC: A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer (clinicaltrials.gov)
    P3, N=480, Recruiting, J-Pharma Co., Ltd. | Initiation date: Jan 2026 --> Apr 2026
    Trial initiation date
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NTRK (Neurotrophic receptor tyrosine kinase)
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    MSI-H/dMMR • HER-2 overexpression • HER-2 amplification • HER-2 mutation • FGFR2 mutation • FGFR2 fusion
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    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • nanvuranlat (JPH203)
    13d
    A Phase I Clinical Study to Evaluate the PK, PD, Efficacy, and Safety of GB18 Injection in Patients With Tumor Cachexia (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, Kexing Biopharm Co., Ltd.
    New P1 trial • First-in-human
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    GDF15 (Growth differentiation factor 15)
    14d
    Clinical significance of circulatory microRNA-183_5p and 3651 in serum as novel potential diagnostic marker for gallbladder cancer. (PubMed, Indian J Gastroenterol)
    Study underscores ability of serum miRNAs 183_5p and 3651 as diagnostic biomarkers for early GBC detection.
    Journal
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    CEACAM5 (CEA Cell Adhesion Molecule 5) • CA 19-9 (Cancer antigen 19-9) • MIR183 (MicroRNA 183)
    14d
    ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors (clinicaltrials.gov)
    P=N/A, N=140, Completed, AstraZeneca | Recruiting --> Completed | N=105 --> 140
    Trial completion • Enrollment change
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden)
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    MSI-H/dMMR • BRAF mutation • HER-2 expression • BRAF wild-type • RAS wild-type • HER-2 positive + RAS wild-type
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    Enhertu (fam-trastuzumab deruxtecan-nxki)
    14d
    HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer (clinicaltrials.gov)
    P=N/A, N=40, Recruiting, Peking University | Not yet recruiting --> Recruiting
    Enrollment open
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    Avastin (bevacizumab) • gemcitabine • 5-fluorouracil • oxaliplatin • leucovorin calcium
    14d
    HERIZON-BTC-302: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer (clinicaltrials.gov)
    P3, N=286, Active, not recruiting, Jazz Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive
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    Keytruda (pembrolizumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine • Ziihera (zanidatamab-hrii)
    15d
    REVEAL-BTC: A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER (clinicaltrials.gov)
    P=N/A, N=244, Not yet recruiting, MedSIR
    New trial
    16d
    Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=160, Recruiting, SystImmune Inc. | N=120 --> 160
    Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CLDN18 (Claudin 18) • NTRK (Neurotrophic receptor tyrosine kinase)
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    PD-L1 expression • KRAS mutation • MSI-H/dMMR • HER-2 overexpression • BRAF mutation • HER-2 mutation • IDH1 mutation • CLDN18.2 expression • FGFR2 mutation • FGFR2 fusion • IDH mutation + NTRK fusion • NTRK fusion