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    CANCER:

    Biliary Tract Cancer

    Related cancers:
    15d
    A randomized phase 2 study of combination atezolizumab and varlilumab (CDX-1127) with or without cobimetinib in previously-treated unresectable biliary tract cancer. (PubMed, Clin Cancer Res)
    The combinations of atezolizumab and varlilumab with/without cobimetinib were safe but neither meaningfully improved outcomes in BTC treated in the later lines. Correlative tissue studies validated preclinical work that MEK inhibition increases CD8+TILs.
    P2 data • Journal
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    CD8 (cluster of differentiation 8) • CD27 (CD27 Molecule)
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    Tecentriq (atezolizumab) • Cotellic (cobimetinib) • varlilumab (CDX 1127)
    16d
    Advanced cholangiocarcinoma in 2025: Therapeutic sequencing and global implementation. (PubMed, Med)
    Chemoimmunotherapy is the reference first-line regimen for biomarker-unselected advanced cholangiocarcinoma. Early comprehensive genomic profiling is essential to enable timely, matched targeted therapy and maximize population-level benefit.
    Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR (Fibroblast Growth Factor Receptor)
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    MSI-H/dMMR • IDH1 mutation • EGFR positive
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    Keytruda (pembrolizumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • oxaliplatin • Tibsovo (ivosidenib) • leucovorin calcium
    16d
    Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=500, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | N=155 --> 500 | Trial completion date: Apr 2029 --> Jun 2031 | Trial primary completion date: Apr 2027 --> Jun 2031
    Enrollment change • Trial completion date • Trial primary completion date • First-in-human
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    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed
    16d
    Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001) (clinicaltrials.gov)
    P1, N=120, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    19d
    The Evolving Landscape of Immune Regulation and Immunotherapy in Cholangiocarcinoma and Biliary Tract Cancer. (PubMed, Cancers (Basel))
    We evaluate the expanding clinical trial landscape of immunotherapy in CCA and more broadly in BTC, including adoptive cell therapies and cancer vaccines. Together, these advances position CCA as a paradigm of how tumor genotype and microenvironment co-evolve to define immunotherapy sensitivity and resistance.
    Review • Journal • IO biomarker
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    KRAS (KRAS proto-oncogene GTPase) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • MTAP (Methylthioadenosine Phosphorylase)
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    KRAS mutation • IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    19d
    Molecular and Clinical Determinants of Targeted Therapy Treatment in Biliary Tract Cancer. (PubMed, Clin Cancer Res)
    This comprehensive molecular profiling study illustrates the real-world utility and limitations of targeted next-generation sequencing of BTC and affirms the use of precision medicine in patients with these diseases. Characterization of genomic heterogeneity and therapeutic resistance has the potential to inform ongoing drug development efforts for BTC.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MET (MET proto-oncogene, receptor tyrosine kinase) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase) • MDM2 (E3 ubiquitin protein ligase) • SMAD4 (SMAD family member 4) • NTRK (Neurotrophic receptor tyrosine kinase)
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    MET amplification • MTAP deletion
    19d
    Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, Peking Union Medical College Hospital
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 expression • HER-2 underexpression
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    Herceptin (trastuzumab) • Lenvima (lenvatinib) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    20d
    An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies (clinicaltrials.gov)
    P2, N=30, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
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    gemcitabine • albumin-bound paclitaxel • AiRuiLi (adebrelimab)
    20d
    Prognostic markers, quality of life (QoL) and value of health (V-He) in advanced biliary cancers (ABC) treated with second-line active symptom control (ASC) alone or ASC with oxaliplatin-5-FU chemotherapy (ASC + FOLFOX) in the randomised phase III, multicentre, open-label ABC-06 clinical trial. (PubMed, ESMO Open)
    In the setting of second-line FOLFOX for ABC, elevated tumour markers impacted on prognosis and could be utilised as stratification factors in future clinical trials. The addition of FOLFOX did not imply QoL deterioration, and did, in fact, preserve some of the status in several domains.
    P3 data • Journal • HEOR
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    CEACAM5 (CEA Cell Adhesion Molecule 5) • MUC16 (Mucin 16, Cell Surface Associated) • CA 19-9 (Cancer antigen 19-9)
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    5-fluorouracil • oxaliplatin • leucovorin calcium
    21d
    Case report: A challenging case of stage IVB mixed neuroendocrine-non-neuroendocrine neoplasm of the gallbladder treated with extended radical resection including portal vein reconstruction. (PubMed, Front Oncol)
    Achieving negative margins through aggressive extended radical surgery may be a feasible treatment option in carefully selected patients; however, the oncological benefit remains to be validated. It emphasizes the critical role of multidisciplinary collaboration in diagnosis and treatment and adds new data to the limited literature on this rare disease.
    Journal
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    CEACAM5 (CEA Cell Adhesion Molecule 5) • KRT19 (Keratin 19)
    21d
    Two cases of durvalumab-induced Evans syndrome in biliary tract cancer. (PubMed, Clin J Gastroenterol)
    They received eight cycles of gemcitabine, cisplatin, and durvalumab, followed by durvalumab monotherapy (five and six cycles, respectively) for a total of approximately 11 months. Corticosteroids remain the cornerstone of treatment, and high-dose pulse therapy may be necessary in refractory cases. In conclusion, recognition of durvalumab-induced ES is crucial for appropriate management.
    Journal
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    PD-L1 (Programmed death ligand 1)
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    cisplatin • Imfinzi (durvalumab) • gemcitabine
    22d
    Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors (clinicaltrials.gov)
    P2, N=58, Active, not recruiting, University Health Network, Toronto | Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Sep 2026 | Trial primary completion date: Mar 2025 --> Sep 2026
    Enrollment closed • Trial completion date • Trial primary completion date • IO biomarker
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    Lynparza (olaparib) • Imfinzi (durvalumab)