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    DRUG:

    Tyvyt (sintilimab)

    i
    Other names: IBI308, IBI 308, IBI-308, LY-3342901
    Company:
    Eli Lilly, Innovent Biologics, Mankind Pharma
    Drug class:
    PD1 inhibitor
    Related drugs:
    1m
    Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy as First-line Treatment for Advanced Gastric Cancer With Liver Metastases (clinicaltrials.gov)
    P3, N=332, Not yet recruiting, Peking University
    New P3 trial
    |
    Tyvyt (sintilimab) • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • retlirafusp alfa (SHR-1701)
    1m
    JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P3, N=600, Recruiting, NingBo Junyan Hongshi Biosciences Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative • CLDN18.2 positive
    |
    Tyvyt (sintilimab) • Loqtorzi (toripalimab-tpzi) • capecitabine • oxaliplatin
    1m
    AAT score based on pretreatment indicators predicts outcomes in unresectable HCC patients treated with TACE, Sintilimab, and Bevacizumab. (PubMed, Front Oncol)
    Kaplan-Meier analysis of OS and progression-free survival (PFS) demonstrated that the AAT score could significantly stratify patients into low (≤1.8), median (>1.8 to ≤3.0), and high (>3.0) risk groups, with distinct 2-year OS rates of 80.0%, 48.0%, and 4.0%, and PFS rates of 63.3%, 56.0%, and 4.0% in the training cohort, validated in the cohort. The AAT model effectively stratifies OS and PFS in uHCC patients undergoing TACE plus sintilimab and bevacizumab, guiding personalized treatment decisions.
    Journal
    |
    AFP (Alpha-fetoprotein)
    |
    Avastin (bevacizumab) • Tyvyt (sintilimab)
    1m
    A Study on the Efficacy and Safety of Sintilimab Combined With Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients With Short-term Recurrence After Adjuvant Therapy (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    paclitaxel • Tyvyt (sintilimab) • Cyramza (ramucirumab)
    1m
    Intensified Adjuvant Therapy for High-Risk Newly Diagnosed Glioblastoma With Subtotal Resection or Short-Term Progression (clinicaltrials.gov)
    P2, N=31, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    Avastin (bevacizumab) • Tyvyt (sintilimab) • temozolomide
    2ms
    Lymphocyte CD4/CD8 ratio predicts early immune-related toxicity in lung cancer patients treated with immune checkpoint inhibitors: a single-center retrospective study. (PubMed, Front Med (Lausanne))
    In this single-center retrospective study (January 2022-December 2025), we included adults with pathologically confirmed advanced NSCLC who received first-line treatment with pembrolizumab, tislelizumab, sintilimab, and camrelizumab. A pre-treatment CD4/CD8 ratio <1.65 remained is a simple, inexpensive biomarker that identifies lung cancer patients at high risk for early irAEs during single-agent PD-1/PD-L1 blockade. Prospective, multicenter validation is warranted.
    Retrospective data • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
    2ms
    STAR-SCLC: Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • Tyvyt (sintilimab) • etoposide IV
    2ms
    Perioperative Fruquintinib Combined With Sintilimab and SOX for Locally Advanced Gastric or GEJ Adenocarcinoma (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Sichuan University
    New P2 trial
    |
    Tyvyt (sintilimab) • oxaliplatin • Fruzaqla (fruquintinib)
    2ms
    Integrated metabolomics and machine learning identify predictive biomarkers via SHAP analysis for sintilimab-induced rash in lung cancer patients. (PubMed, Front Pharmacol)
    Distinct clinical and metabolomic alterations are associated with sintilimab-induced rash in lung cancer patients. The identified differential metabolites may serve as predictive biomarkers and potential therapeutic targets, providing new insights for clinical management and mechanistic research into immune-related adverse events.
    Journal • Metabolomic study
    |
    CRP (C-reactive protein)
    |
    Tyvyt (sintilimab)
    2ms
    Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=32, Not yet recruiting, Peking University People's Hospital
    New P2 trial • pMMR
    |
    Tyvyt (sintilimab) • R-(-)-gossypol (AT 101)
    2ms
    Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | N=40 --> 27 | Trial completion date: Sep 2027 --> Jun 2036 | Trial primary completion date: Apr 2027 --> Jun 2036
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    5-fluorouracil • Tyvyt (sintilimab) • irinotecan • leucovorin calcium
    2ms
    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
    |
    Yervoy (ipilimumab) • gemcitabine • Tyvyt (sintilimab) • albumin-bound paclitaxel