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    DRUG:

    Hetronifly (serplulimab)

    i
    Other names: HLX10, HLX 10, HLX-10
    Company:
    Eisai, Fosun Pharma, Intas, Lotus Pharmaceutical, PT Kalbe Farma
    Drug class:
    PD1 inhibitor
    Related drugs:
    1d
    SCAR: Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Zhejiang University | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab) • celecoxib oral
    1d
    A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=167, Recruiting, Shanghai Henlius Biotech | N=90 --> 167 | Trial completion date: Jul 2028 --> Jan 2029
    Enrollment change • Trial completion date
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07) • HLX43
    3d
    FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer (clinicaltrials.gov)
    P4, N=42, Not yet recruiting, Ye Xu
    New P4 trial • Tumor mutational burden • pMMR
    |
    MSI (Microsatellite instability)
    |
    5-fluorouracil • oxaliplatin • Fruzaqla (fruquintinib) • leucovorin calcium • Hetronifly (serplulimab)
    3d
    NAPTSOX24: Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Zekuan Xu | Trial primary completion date: May 2025 --> Jan 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    oxaliplatin • Hetronifly (serplulimab) • Zadaxin (thymalfasin)
    8d
    Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial. (PubMed, BMC Med)
    Neoadjuvant serplulimab, SOX, and thymalfasin produced encouraging pathological response, substantial nodal clearance, and an acceptable safety profile in stage III G/EGJ adenocarcinoma. Peripheral immune and transcriptomic profiling are consistent with a hypothesis in which thymalfasin may help preserve and coordinate systemic antitumor immunity without excessive toxicity. These findings warrant further larger randomized trials.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD69 (CD69 Molecule)
    |
    oxaliplatin • Hetronifly (serplulimab) • Teysuno (gimeracil/oteracil/tegafur) • Zadaxin (thymalfasin)
    17d
    FANLUNG-2：The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, Fudan University
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • MET exon 14 mutation • RET mutation • MET mutation • KRAS G12
    |
    5-fluorouracil • Hetronifly (serplulimab)
    23d
    Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC (clinicaltrials.gov)
    P2, N=22, Not yet recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    New P2 trial
    |
    cisplatin • carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)
    24d
    ECTOP-1036: Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC (clinicaltrials.gov)
    P2, N=116, Recruiting, Fudan University
    New P2 trial
    |
    Opdivo (nivolumab) • carboplatin • paclitaxel • Hetronifly (serplulimab)
    1m
    Long-term survival in extensive-stage small cell lung cancer: a case report on the integration of interventional bronchoscopy and systemic immunotherapy. (PubMed, Front Oncol)
    The patient initially responded to platinum-etoposide chemotherapy but experienced treatment interruption during the COVID-19 pandemic, followed by recurrent malignant airway obstruction and respiratory failure...Subsequently, chemotherapy combined with the programmed cell death protein-1 (PD-1) inhibitor serplulimab was initiated, followed by maintenance immunotherapy...At five years after initial diagnosis, the patient remains alive with stable disease and without severe treatment-related adverse events. This case highlights the potential role of integrating bronchoscopic local interventions with systemic chemotherapy and immunotherapy to enable durable disease control and long-term survival in selected patients with ES-SCLC complicated by central airway obstruction.
    Journal
    |
    IL6 (Interleukin 6)
    |
    etoposide IV • Hetronifly (serplulimab)
    1m
    Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study) (clinicaltrials.gov)
    P2, N=128, Not yet recruiting, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    New P2 trial • pMMR
    |
    MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Hetronifly (serplulimab)
    1m
    TAS-102 plus Fruquintinib or TAS-102 plus Fruquintinib in combination with Chidamide and Serplulimab as third-line and beyond treatment for metastatic colorectal cancer：A multicenter, randomized, two-arm clinical trial (ChiCTR2500115578)
    P4, N=64, Not yet recruiting, The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University
    New P4 trial
    |
    Fruzaqla (fruquintinib) • Epidaza (chidamide) • Lonsurf (trifluridine/tipiracil) • Hetronifly (serplulimab)
    1m
    A clinical study of carboplatin/albumin paclitaxel combined with PD-L1 inhibitor as neoadjuvant therapy for resectable Cervical Esophageal Squamous Cell Carcinoma (ChiCTR2500114965)
    P2, N=30, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)