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    GENE:

    MSI (Microsatellite instability)

    i
    Other names: MSI | Microsatellite instability
    1d
    Copy-number amplification drives IFI30 overexpression and coordinated immune activation, identifying a novel diagnostic and therapeutic target in gastric adenocarcinoma. (PubMed, Sci Rep)
    Its high expression integrates tumor-intrinsic programs (cell cycle, EMT, hypoxia) with tumor-extrinsic immune activation, predicts differential drug sensitivities, and outperforms established biomarkers in forecasting response to immune-checkpoint blockade-particularly in MSI-high disease. These findings nominate IFI30 as a promising diagnostic marker and therapeutic target.
    Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IRF1 (Interferon Regulatory Factor 1) • SPI1 (Spi-1 Proto-Oncogene) • FOXP3 (Forkhead Box P3)
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    MSI-H/dMMR
    1d
    Successful treatment of synchronous double lung and colon cancers using immune checkpoint inhibitors. (PubMed, Intern Med)
    Subsequent testing revealed high-frequency microsatellite instability (MSI-H) in the colon cancer. These findings highlight the therapeutic potential of combined anti-PD-L1 and anti-CTLA-4 antibodies in the treatment of PD-L1-negative lung and MSI-H colorectal cancers.
    Journal • Checkpoint inhibition
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    MSI (Microsatellite instability)
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    MSI-H/dMMR • PD-L1 negative
    1d
    Neoadjuvant PD-1/PD-L1 inhibitors plus chemotherapy in locally advanced gastric cancer: a systematic review and meta-analysis. (PubMed, Crit Rev Oncol Hematol)
    Meta-regression revealed no significant effect modification. Overall, nICT provides pathological and early survival improvement without compromising perioperative safety, supporting its integration into perioperative strategies for LAGC/EGJC.
    Retrospective data • Review • Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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    MSI-H/dMMR
    2d
    A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
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    Keytruda (pembrolizumab) • Lenvima (lenvatinib)
    2d
    Neoadjuvant modified FOLFIRINOX plus nivolumab in borderline-resectable pancreatic ductal adenocarcinoma: a pilot phase 1 trial. (PubMed, Nat Commun)
    In post-hoc analyses, median progression-free survival was 26 months (95% CI: 14.7-34.3), and median overall survival was 38 months (95% CI: 27.9-not reached). Exploratory gene expression, immunohistochemistry and spatial transcriptomics showed increased intratumoral plasma cells and CD8 T cells in treated patients versus mFFX-only controls, and lymphoid aggregates with high plasma-cell-to-B cell ratios enriched for terminally exhausted CD8 T cells with fewer progenitor exhausted CD8 T cells and central memory CD4 T cells.
    P1 data • Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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    MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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    MSI-H/dMMR
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    Opdivo (nivolumab) • 5-fluorouracil • irinotecan • leucovorin calcium
    3d
    Factors Influencing Immunotherapy Response in dMMR/MSI-H Gastric/Gastroesophageal Junction Adenocarcinoma (ChiCTR2500113343)
    P=N/A, N=55, Not yet recruiting, Zhongshan Hospital, Fudan Univeristy; Zhongshan Hospital, Fudan Univeristy
    New trial
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    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
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    MSI-H/dMMR
    3d
    A study on the treatment of advanced gastric/gastroesophageal junction adenocarcinoma with docetaxel for injection (albumin-bound type) combined with oxaliplatin and 5-FU/LV (ADOF) (ChiCTR2500112147)
    P=N/A, N=12, Not yet recruiting, Fujian Cancer Hospital; CSPC Zhongqi Pharmaceutical Technology Co., Ltd.
    New trial
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
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    PD-L1 expression • MSI-H/dMMR • HER-2 overexpression
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    5-fluorouracil • oxaliplatin • albumin-bound docetaxel (CPO100)
    3d
    A Real-World Study of Precision Treatment for Advanced Cholangiocarcinoma Based on Molecular Subtyping (ChiCTR2500111407)
    P=N/A, N=55, Not yet recruiting, Fuzhou University Affiliated Provincial Hospital; Fuzhou University Affiliated Provincial Hospital
    New trial
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MET (MET proto-oncogene, receptor tyrosine kinase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NRG1 (Neuregulin 1) • VEGFA (Vascular endothelial growth factor A) • RNF43 (Ring Finger Protein 43) • TYK2 (Tyrosine Kinase 2) • NTRK (Neurotrophic receptor tyrosine kinase)
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    BRAF V600E • KRAS mutation • EGFR mutation • MSI-H/dMMR • HER-2 overexpression • HER-2 amplification • PIK3CA mutation • BRAF V600 • MET amplification • RET fusion • FGFR2 mutation • PALB2 mutation • FGFR2 fusion • MET mutation • IDH mutation + BRAF V600E • IDH mutation + NTRK fusion
    3d
    Sulfasalazine combined with fruquintinib and sintilimab‌ for ‌third-line or later treatment of advanced pMMR/MSS colorectal cancer: an open-label, single-arm, exploratory study. (ChiCTR2600116822)
    P2, N=37, Not yet recruiting, The First Afliated Hospital of Anhui Medical University; The First Afliated Hospital of Anhui Medical University
    New P2 trial
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    MSI (Microsatellite instability)
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    Tyvyt (sintilimab) • Fruzaqla (fruquintinib)
    3d
    Iparomlimab and Tuvonralimab combined with fruquintinib in the treatment of dMMR/MSI-H colorectal cancer that has failed previous immune checkpoint inhibitor therapy: a single-center, single-arm, IIT trial (ChiCTR2500111438)
    P2, N=17, Not yet recruiting, Shanghai East Hospital; Shanghai East Hospital
    New P2 trial
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
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    Fruzaqla (fruquintinib) • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    3d
    Iparomlimab and Tuvonralimab in Combination with Nab-Paclitaxel and Apatinib as Second-Line Therapy for Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma: A Single-Center, Single-Arm IIT Study (ChiCTR2500111595)
    P2, N=20, Not yet recruiting, Shanghai East Hospital; Shanghai East Hospital
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability)
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    HER-2 negative
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    AiTan (rivoceranib) • albumin-bound paclitaxel • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    3d
    Neoadjuvant Iparomlimab and Tuvonralimab for Resectable MSI-H/dMMR Gastric or Gastroesophageal Junction Cancer (NIT-GC study): a single-arm, openlabel, phase 2 trial (ChiCTR2500111960)
    P2, N=48, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2 trial
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
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    Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)