^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    CANCER:

    Biliary Tract Cancer

    Related cancers:
    1d
    The effect of metabolism-related lifestyle and clinical risk factors on digestive system cancers in East Asian populations: a two-sample Mendelian randomization analysis. (PubMed, Sci Rep)
    The leave-one-out analysis revealed that the single nucleotide polymorphism (SNP) rs671 from the ALDH2 gene has a disproportionately high contribution to the causal association between alcohol drinking and gastric cancer and hepatocellular carcinoma, as well as the association between coffee consumption and hepatocellular carcinoma. The present study revealed multiple metabolism-related lifestyle and clinical risk factors and a valuable SNP rs671 for DSCs, highlighting the significance of metabolic factors in both the prevention and treatment of DSCs.
    Journal
    |
    ALDH2 (Aldehyde Dehydrogenase 2 Family Member)
    2d
    The histone lysine acetyltransferase KAT2B inhibits cholangiocarcinoma growth: evidence for interaction with SP1 to regulate NF2-YAP signaling. (PubMed, J Exp Clin Cancer Res)
    This study provides the first evidence for an important tumor inhibitory effect of KAT2B in CCA through regulation of NF2-YAP signaling and suggests that this signaling cascade may be therapeutically targeted for CCA treatment.
    Journal
    |
    NF2 (Neurofibromin 2)
    2d
    Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=78, Active, not recruiting, Symphogen A/S | N=148 --> 78 | Trial completion date: Jan 2025 --> Jun 2024
    Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    |
    irinotecan • S95018 • Sym021 • Sym022
    3d
    Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • gemcitabine • AiTan (rivoceranib) • adebrelimab (SHR-1316)
    7d
    Efficacy and biomarker analysis of second-line nab-paclitaxel plus sintilimab in patients with advanced biliary tract cancer. (PubMed, Cancer Sci)
    Nab-paclitaxel plus sintilimab is a potentially effective and tolerable second-line regimen for advanced BTC that deserves to be studied in large-scale trials. PD-L1 status and CD8+ T cell infiltration might be promising biomarkers for efficacy prediction.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Tyvyt (sintilimab) • albumin-bound paclitaxel
    7d
    BTC-BGB: Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, Seoul National University Hospital | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • sitravatinib (MGCD516)
    7d
    DDR-Umbrella Study of DDR Targeting Agents in Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=74, Active, not recruiting, Seoul National University Hospital | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Metastases
    |
    Lynparza (olaparib) • Imfinzi (durvalumab) • ceralasertib (AZD6738)
    7d
    AZD6738 Plus Durvalumab in Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=26, Recruiting, Seoul National University Hospital | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    Imfinzi (durvalumab) • ceralasertib (AZD6738)
    7d
    Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Seoul National University Hospital | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Combination therapy
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
    9d
    Phase II trial of niraparib for BRCA-mutated biliary tract, pancreatic and other gastrointestinal cancers: NIR-B. (PubMed, Future Oncol)
    The primary end point is an investigator-assessed objective response rate in each cohort. Clinical Trial Registration: jRCT2011200023 (ClinicalTrials.gov).
    P2 data • Review • Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HRD • BRCA mutation
    |
    Zejula (niraparib)
    9d
    A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC) (clinicaltrials.gov)
    P1/2, N=60, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Keytruda (pembrolizumab) • capecitabine • oxaliplatin • CDX-1140
    9d
    Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1, N=17, Completed, Turning Point Therapeutics, Inc. | Active, not recruiting --> Completed | N=42 --> 17
    Trial completion • Enrollment change • Metastases
    |
    MSI (Microsatellite instability) • CLDN18 (Claudin 18)
    |
    MSI-H/dMMR • CLDN18.2 expression • CLDN18.2 positive
    |
    BMS-986476
    10d
    Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI (clinicaltrials.gov)
    P=N/A, N=200, Recruiting, AstraZeneca | Trial completion date: Nov 2025 --> Jul 2026 | Trial primary completion date: Nov 2025 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    Imfinzi (durvalumab)
    10d
    The efficacy of ferroptosis-inducing compounds IKE and RSL3 correlates with the expression of ferroptotic pathway regulators CD71 and SLC7A11 in biliary tract cancer cells. (PubMed, PLoS One)
    Our results demonstrate that induction of ferroptosis is a promising approach to inhibit BTC cell growth and that the sensitivity of BTC cells towards ferroptosis induction might be dependent on molecular markers such as CD71 and SLC7A11.
    Journal
    |
    TFRC • SLC7A11 (Solute Carrier Family 7 Member 11)
    |
    SLC7A11 expression
    |
    RSL3
    12d
    A MiR181/Sirtuin1 regulatory circuit modulates drug response in biliary cancers. (PubMed, Clin Exp Med)
    An integrative network analysis demonstrated that, miR-181/SIRT1 circuit had a regulatory effect on several important metabolic tumor-related processes. Our study demonstrated that miR-181c and -181d act as tumor suppressor miRNA in BTC, suggesting the potential use as therapeutic strategy in resistant cancers and as predictive biomarker in the precision medicine of BTC.
    Journal
    |
    SIRT1 (Sirtuin 1) • MIR181C (MicroRNA 181c)
    14d
    Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=300, Recruiting, Peking Union Medical College Hospital
    New P2 trial • Metastases
    |
    cisplatin • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • oxaliplatin
    16d
    MicroRNA-34a-5p: A pivotal therapeutic target in gallbladder cancer. (PubMed, Mol Ther Oncol)
    In a murine xenograft model, locally injected microRNA-34a-5p mimics significantly inhibited gallbladder cancer progression and downregulated CDK6 expression. These results provide a rationale for promising therapeutics against gallbladder cancer by microRNA-34a-5p injection, as well as a strategy to explore therapeutic targets against cancers using organoid-based models, especially for those lacking useful genetically engineered murine models, such as gallbladder cancer.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • CDK6 (Cyclin-dependent kinase 6) • MIR34A (MicroRNA 34a-5p)
    |
    KRAS G12D • KRAS G12 • CDK6 expression
    16d
    TranStar102: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=320, Recruiting, Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Apr 2024 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • cisplatin • gemcitabine • paclitaxel • capecitabine • oxaliplatin • osemitamab (TST001)
    16d
    Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC) (clinicaltrials.gov)
    P2, N=15, Terminated, Massachusetts General Hospital | N=30 --> 15 | Recruiting --> Terminated; Based on a Simon 2-stage design, this study did not meet response criteria to proceed to stage 2.
    Enrollment change • Trial termination • Metastases
    |
    Opdivo (nivolumab) • sirexatamab (DKN-01)
    17d
    The causal relationship between cathepsins and digestive system tumors: a Mendelian randomization study. (PubMed, Front Oncol)
    Lastly, high levels of cathepsin L2 were found to lower the risk of CRC (IVW: p = 0.034, OR = 0.814, 95% CI = 0.674-0.985). Our findings confirm the causal relationship between cathepsins and digestive system tumors, which can offer valuable insights for the diagnosis and treatment of digestive system tumors.
    Journal • Causal relationship
    |
    CTSS (Cathepsin S) • CTSG (Cathepsin G)
    17d
    RBM10 C761Y mutation induced oncogenic ASPM isoforms and regulated β-catenin signaling in cholangiocarcinoma. (PubMed, J Exp Clin Cancer Res)
    Our results showed that RBM10C761Y-modulated ASPM203 promoted CCA progression in a Wnt/β-catenin signaling-dependent manner. This study may enhance the understanding of the regulatory mechanisms that link mutation-altering splicing variants to CCA.
    Journal
    |
    SRSF2 (Serine and arginine rich splicing factor 2) • RBM10 (RNA Binding Motif Protein 10)
    |
    SRSF2 mutation • RBM10 mutation
    17d
    FAPIChol: The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma (clinicaltrials.gov)
    P2/3, N=81, Not yet recruiting, Mara Veenstra, MD
    New P2/3 trial • Cost effectiveness
    17d
    Management of biliary tract cancers in early-onset patients: A nested multicenter retrospective study of the ACABI GERCOR PRONOBIL cohort. (PubMed, Liver Int)
    Patients with EOBTC have a more advanced disease at diagnosis, are treated more heavily at an advanced stage but show similar survival. A distinctive molecular profile enriched for FGRF2 fusions was found.
    Retrospective data • Journal
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    21d
    Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2028 --> May 2028 | Trial primary completion date: Feb 2028 --> May 2028
    Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • CD68 (CD68 Molecule)
    |
    ARG1 overexpression • CD163 expression
    |
    Keytruda (pembrolizumab) • cisplatin • gemcitabine
    30d
    Construction of a Human Immune Library from Gallbladder Cancer Patients for the Single-Chain Fragment Variable (scFv) Antibody Selection against Claudin 18.2 via Phage Display. (PubMed, Antibodies (Basel))
    After three rounds of panning, we were able to identify clones with specificity against claudin 18.2. GALLBLA1 can contribute to the selection, isolation, and recombinant production of new human mAbs candidates for the treatment of gastrointestinal cancers.
    Journal
    |
    CLDN18 (Claudin 18)
    1m
    NIRADO: Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (clinicaltrials.gov)
    P2, N=51, Suspended, Gustave Roussy, Cancer Campus, Grand Paris | N=112 --> 51 | Trial completion date: Mar 2027 --> Dec 2027 | Recruiting --> Suspended | Trial primary completion date: Mar 2024 --> Dec 2024
    Enrollment change • Trial completion date • Trial suspension • Trial primary completion date • Pan tumor
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • ARID1A (AT-rich interaction domain 1A) • PBRM1 (Polybromo 1) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • ARID2 (AT-Rich Interaction Domain 2) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • RAD54L (DNA Repair And Recombination Protein RAD54) • DRD (DNA Repair Deficiency)
    |
    HER-2 positive • HER-2 amplification • DDR • PBRM1 mutation • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • FANCA mutation • RAD51D mutation • BARD1 mutation • NBN mutation • DRD
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    1m
    Transgelin-2, a novel cancer stem cell-related biomarker, is a diagnostic and therapeutic target for biliary tract cancer. (PubMed, BMC Cancer)
    TAGLN2 plays a critical role in promoting BTC cell growth and motility and is involved in regulating BTC stemness. Silencing TAGLN2 expression enhanced cell sensitivity to radiation and chemotherapeutic drugs. The expression of TAGLN2 in patient tissue and plasma suggests its potential to serve as a secretory biomarker for BTC. Overall, targeting TAGLN2 could be an appropriate therapeutic strategy against advanced cancer following chemotherapy failure.
    Journal • Cancer stem
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    TAGLN expression
    |
    gemcitabine
    1m
    Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC) (clinicaltrials.gov)
    P2, N=43, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P2 trial • Combination therapy • Metastases
    |
    PD-L1 expression
    |
    gemcitabine • sorafenib • AiTan (rivoceranib) • oxaliplatin • adebrelimab (SHR-1316)
    1m
    Phase II study of nivolumab in patients with genetic alterations in DNA damage repair and response who progressed after standard treatment for metastatic solid cancers (KM-06). (PubMed, J Immunother Cancer)
    In this phase II trial, nivolumab demonstrated moderate efficacy and manageable toxicity in patients with solid cancer harboring DDR gene mutations. A high TMB (>12 mut/Mb) and MSI score (>2.5) determined through clinically target sequencing presented significant discriminatory power for the nivolumab response.
    P2 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8)
    |
    TMB-H
    |
    Opdivo (nivolumab)
    1m
    Biliary tract cancers: French national clinical practice guidelines for diagnosis, treatments and follow-up (TNCD, SNFGE, FFCD, UNICANCER, GERCOR, SFCD, SFED, AFEF, SFRO, SFP, SFR, ACABi, ACHBPT). (PubMed, Eur J Cancer)
    These guidelines are intended to provide a personalised therapeutic strategy for daily clinical practice. Each individual BTC case should be discussed by a multidisciplinary team.
    Clinical guideline • Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    BRAF V600E • MSI-H/dMMR • HER-2 amplification • BRAF V600 • IDH1 mutation • FGFR2 mutation • FGFR2 rearrangement
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • 5-fluorouracil • capecitabine • leucovorin calcium
    1m
    Efficacy and predictors of immune checkpoint inhibitors in patients with gallbladder cancer. (PubMed, Cancer Sci)
    These results suggest that ICIs were effective in patients with GBC. High CEA level, cutaneous irAEs, high CD8+ T cell infiltration, and immune inflamed phenotype could be useful for predicting the efficacy of ICIs in GBC.
    Journal • Checkpoint inhibition • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    CD8-H
    1m
    Clonal analysis of metachronous double biliary tract cancers. (PubMed, J Pathol)
    © 2024 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland
    Journal
    |
    TP53 (Tumor protein P53) • STK11 (Serine/threonine kinase 11) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ARID1A (AT-rich interaction domain 1A) • NF1 (Neurofibromin 1) • KMT2D (Lysine Methyltransferase 2D) • RNF43 (Ring Finger Protein 43) • SMAD4 (SMAD family member 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • GNAS (GNAS Complex Locus) • ELF3 (E74 Like ETS Transcription Factor 3)
    |
    TP53 expression
    1m
    Hepatic arterial infusion chemotherapy combined with bevacizumab plus a PD-1 inhibitor for gallbladder cancer with hepatic oligometastasis: a real-world study. (PubMed, J Gastrointest Oncol)
    The combination of HAIC, a PD-1 inhibitor, and bevacizumab shows potential for advanced GBC with hepatic oligometastasis. The therapeutic response of hepatic metastasis had a greater influence on prognosis than that of primary gallbladder lesions.
    Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Avastin (bevacizumab)
    1m
    Current Status of Targeted Therapy for Biliary Tract Cancer in the Era of Precision Medicine. (PubMed, Cancers (Basel))
    Advances in comprehensive genomic analysis revealed that nearly half of patients with BTC harbor targetable genetic alterations such as fibroblast growth factor receptor (FGFR), isocitrate dehydrogenase (IDH), BRAF, human epidermal growth factor receptor 2 (HER2), microsatellite instability (MSI)-high, neurotrophic tropomyosin receptor kinase (NTRK), rearranged during transfection (RET), and poly (adenosine diphosphate-ribose) polymerase (PARP). This review summarizes currently available options in precision medicine and clinical trials for patients with advanced BTC.
    Review • Journal • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • FGFR (Fibroblast Growth Factor Receptor) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    1m
    Extracellular RNA Markers of Liver Disease and Cancer (clinicaltrials.gov)
    P=N/A, N=1810, Active, not recruiting, Mayo Clinic | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2025 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    AFP (Alpha-fetoprotein)
    1m
    A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1, N=140, Recruiting, Boehringer Ingelheim | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 mutation • TP53 wild-type • TP53 amplification
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    1m
    A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    BL-M07D1
    2ms
    Immunotherapy for the treatment of biliary tract cancer: an evolving landscape. (PubMed, Ther Adv Med Oncol)
    We further analyze the culmination of these advances, which resulted in the approval of durvalumab with gemcitabine and cisplatin for the first-line treatment of BTC per TOPAZ-1. We also discuss the results of KEYNOTE-966, which similarly reported improved clinical outcomes with the use of pembrolizumab in combination with gemcitabine and cisplatin.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    Keytruda (pembrolizumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine
    2ms
    Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases (clinicaltrials.gov)
    P1, N=12, Recruiting, City of Hope Medical Center | Trial completion date: Mar 2024 --> Oct 2028 | Trial primary completion date: Mar 2024 --> Oct 2028
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    cisplatin • gemcitabine • albumin-bound paclitaxel
    2ms
    TopDouble: A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC) (clinicaltrials.gov)
    P3, N=116, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Imfinzi (durvalumab) • gemcitabine
    2ms
    The association of mismatch repair gene alterations with elevated tumor mutational burden in microsatellite stable gastrointestinal cancers (AACR 2024)
    MMR gene alterations can be identified by clinical NGS platforms in a small proportion of patients with MSS GI cancers. They are associated with elevated TMB, which may suggest a hypermutated profile serving as a basis for potential role of immune checkpoint inhibitor in MSS GI cancers.
    Tumor mutational burden • MSi-H Biomarker • IO biomarker • Mismatch repair
    |
    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • SMAD4 (SMAD family member 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • PMS2 (PMS1 protein homolog 2)
    |
    MSI-H/dMMR
    |
    Guardant360® CDx
    2ms
    PD-L1 antigen stability using PD-L1 IHC pharmDx on human cancer tissues (AACR 2024)
    Diagnostic evaluation and selection of potential pembrolizumab-responsive patients is achieved by determining the programmed cell death ligand-1 (PD-L1) expression using the companion diagnostic PD-L1 IHC 22C3 pharmDx assay, for several indications...These data provide high confidence in determining PD-L1 expression on properly stored aged cut sections. Commercial claims may be shorter based on region, as specified in the local instructions for use.
    PD(L)-1 Biomarker • IO biomarker • PD(L)-1 companion diagnostic • IO Companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab)