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    CANCER:

    Biliary Tract Cancer

    Related cancers:
    1d
    SIAG-BTC: Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC. (clinicaltrials.gov)
    P2, N=107, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
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    Yervoy (ipilimumab) • gemcitabine • Tyvyt (sintilimab) • albumin-bound paclitaxel
    2d
    Cholangiocarcinoma in the Era of Precision Medicine: Emerging Insights and Therapeutic Strategies. (PubMed, Curr Pharm Des)
    Advances in molecular profiling and immunotherapy are reshaping the management of cholangiocarcinoma, enabling more personalized treatment strategies. Continued integration of precision oncology into clinical practice and prospective trials will be critical to improving outcomes for cholangiocarcinoma moving forward.
    Journal
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    MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR (Fibroblast Growth Factor Receptor)
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    cisplatin • gemcitabine • capecitabine
    2d
    Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, HuiKai Li
    New P2 trial
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    EGFR (Epidermal growth factor receptor)
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    EGFR expression
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    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    3d
    SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors (clinicaltrials.gov)
    P2, N=150, Recruiting, Shenyang Sunshine Pharmaceutical Co., LTD.
    New P2 trial
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    SSGJ-705
    3d
    Proof-of-principle 4-marker spatial profiling reveals distinct, location-independent immune clusters in biliary tract cancers. (PubMed, Pathol Oncol Res)
    Despite advances with durvalumab plus chemotherapy, prognosis remains poor. However, among patients treated with adjuvant cisplatin/gemcitabine alone, lower CD20/CD8 fractions and higher CD163 abundance at baseline were associated with improved survival. Spatial immune profiling revealed distinct BTC immune architectures at the invasive margin, with different possible impact on survival, thus warranting further characterization and validation in larger cohorts.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    TP53 (Tumor protein P53) • CD20 (Membrane Spanning 4-Domains A1) • ARID1A (AT-rich interaction domain 1A) • CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • CD4 (CD4 Molecule)
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    cisplatin • Imfinzi (durvalumab) • gemcitabine
    5d
    Comprehensive Genomic Profiles of Patients With Biliary Tract Cancer. (PubMed, Cancer Med)
    We demonstrated the real-world genomic characteristics of BTC patients, which may have promising implications for the development and application of precision medicine in the future. Well-designed prospective studies are mandatory to validate the predictive role of significant genomic alterations observed in our study.
    Journal
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    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • FGFR2 (Fibroblast growth factor receptor 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • NF1 (Neurofibromin 1) • LRP1B (LDL Receptor Related Protein 1B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • MSH3 (MutS Homolog 3)
    6d
    A Phase I Clinical Study to Evaluate the Efficacy and Safety of GB18 Injection in Patients With Tumor Cachexia (clinicaltrials.gov)
    P1, N=18, Recruiting, Kexing Biopharm Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
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    GDF15 (Growth differentiation factor 15)
    6d
    IMC001 EpCAM: Phase I/IIa Clinical Trial of IMC001 in Patients With Advanced Epithelial Solid Tumors. (clinicaltrials.gov)
    P1/2, N=30, Enrolling by invitation, Suzhou Immunofoco Biotechnology Co., Ltd
    New P1/2 trial
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    IMC001 • danburstotug (IMC-001)
    6d
    A Phase Ib/II Clinical Study of Camrelizumab and Apatinib Plus GP in the Treatment of Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P1/2, N=48, Completed, Sun Yat-sen University | Not yet recruiting --> Completed | Trial completion date: Dec 2024 --> May 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    cisplatin • gemcitabine • AiRuiKa (camrelizumab) • AiTan (rivoceranib)
    6d
    Extracellular matrix biomarkers of T-cell infiltration and tumor fibrosis predict response to nivolumab ± ipilimumab with SBRT in biliary tract cancer: insights from the CheckPAC trial. (PubMed, BMC Med)
    Serological biomarkers reflecting tumor fibrosis (PRO-C3) and cytotoxic T-cell infiltration (C4G) were associated with clinical benefit and OS and showed pharmacodynamic changes during therapy in patients with metastatic BTC treated with SBRT plus ICI. These biomarkers enable tracking of pharmacodynamic response to ICI, while independent validation is necessary to ensure their predictive utility in immunotherapy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    GZMB (Granzyme B)
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    Opdivo (nivolumab) • cisplatin • Yervoy (ipilimumab) • gemcitabine
    7d
    D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P3, N=195, Recruiting, InnoPharmax Inc. | Not yet recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • FGFR (Fibroblast Growth Factor Receptor) • NTRK (Neurotrophic receptor tyrosine kinase)
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    KRAS mutation • TMB-H • KRAS G12C • BRAF mutation • KRAS G12
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    5-fluorouracil • capecitabine • irinotecan • leucovorin calcium • gemcitabine oral (D07001)
    7d
    DUET-BTC: Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Beijing Biotech
    New P1/2 trial
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    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    HER-2 positive • HER-2 amplification
    |
    cyclophosphamide • fludarabine IV