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    DRUG:

    Zepsun (donafenib)

    i
    Other names: CM4307, CM-4307, CM 4307
    Company:
    Suzhou Zelgen
    Drug class:
    Multi-tyrosine kinase inhibitor, cRAF inhibitor
    Related drugs:
    5d
    CHANCE2202: TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Intermediate HCC (clinicaltrials.gov)
    P=N/A, N=941, Completed, Zhongda Hospital | Recruiting --> Completed | N=220 --> 941 | Trial completion date: Sep 2023 --> Sep 2025
    Trial completion • Enrollment change • Trial completion date
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • sorafenib • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib) • Zepsun (donafenib)
    5d
    CHANCE2201: TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Advanced HCC (clinicaltrials.gov)
    P=N/A, N=1244, Completed, Zhongda Hospital | Recruiting --> Completed | N=474 --> 1244
    Trial completion • Enrollment change
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • sorafenib • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib) • Zepsun (donafenib)
    8d
    Laparoscopic right caudate lobectomy combined with right posterior lobectomy for hepatocellular carcinoma after neoadjuvant therapy (with video). (PubMed, Surg Oncol)
    Our findings demonstrate that laparoscopic caudate lobectomy after neoadjuvant therapy is a feasible approach for managing resectable HCC with high risk of recurrence located in the caudate lobe.
    Journal • Video
    |
    AFP (Alpha-fetoprotein)
    |
    Tyvyt (sintilimab) • Zepsun (donafenib)
    1m
    Combinatorial treatment with donafenib and quercetin suppresses lipid metabolism in HepG2 cells by targeting the CREB1/DRP1/SREBP1 axis. (PubMed, Transl Cancer Res)
    These findings indicate that the combination of QUE and DON exerts its antitumor effects by inhibiting the CREB1/DRP1/SREBP1 axis mediated lipid metabolism pathway in HepG2 cells. This offers a novel potential approach for enhancing the therapeutic efficacy of DON in the treatment of HCC.
    Journal
    |
    CREB1 (CAMP Responsive Element Binding Protein 1)
    |
    Zepsun (donafenib)
    2ms
    PATH: Study on the Safety and Efficacy of Donafinib Combined With Anti-PD-1 Antibody as Adjuvant Therapy for HCC Patients (clinicaltrials.gov)
    P1, N=30, Completed, Zhejiang University | Recruiting --> Completed | Trial completion date: Jun 2024 --> Nov 2025 | Trial primary completion date: Dec 2023 --> Nov 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Zepsun (donafenib)
    2ms
    Synergistic antitumor effect of oroxylin A and donafenib in hepatocellular carcinoma through tumor protein p53 signaling pathway activation. (PubMed, World J Gastroenterol)
    Oroxylin A and donafenib exert a synergistic anti-tumor effect in HCC by co-activating the TP53 signaling pathway through distinct but complementary molecular axes. This combination strategy presents a promising and viable therapeutic approach to overcome the limitations of donafenib monotherapy in the treatment of HCC.
    Journal
    |
    MDM4 (The mouse double minute 4) • CDK9 (Cyclin Dependent Kinase 9)
    |
    Zepsun (donafenib)
    2ms
    Effects of Cytochrome P450 enzymes and drug-drug interaction on donafenib metabolism: in vivo, in vitro and in silico. (PubMed, Bioorg Chem)
    This study systematically elucidated the metabolic characteristics of the hepatocellular carcinoma (HCC) therapeutic drug donafenib and its drug-drug interaction (DDI) with the antiviral agent arbidol. Moreover, Tmax was prolonged by 68.42%, while CLz/F was decreased by 53.85%. These results provided critical references for clinical dosage adjustment, facilitating personalized treatment and reducing the risk of adverse reactions.
    Preclinical • Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    Zepsun (donafenib)
    2ms
    Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies. (clinicaltrials.gov)
    P2, N=76, Completed, Fudan University | Recruiting --> Completed | Phase classification: P4 --> P2 | N=53 --> 76 | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Feb 2025 --> Sep 2025
    Trial completion • Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Adverse events
    |
    sorafenib • Lenvima (lenvatinib) • AiTan (rivoceranib) • Stivarga (regorafenib) • Zepsun (donafenib)
    3ms
    Prospective Cohort Study on the Efficacy and Safety of Sequential TIPS-TACE/HAIC Combined or Not Combined with Donafenib and Tislelizumab in the Treatment of BCLC Stage C Hepatocellular Carcinoma Patients with Concomitant Portal Hypertension (ChiCTR2600116845)
    P=N/A, N=96, Not yet recruiting, Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University
    New trial
    |
    Tevimbra (tislelizumab-jsgr) • Zepsun (donafenib)
    3ms
    Pharmacokinetics and Individualized Dose Optimization of Donafenib in Hepatocellular Carcinoma Patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) (ChiCTR2500115846)
    P=N/A, N=20, Not yet recruiting, Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University
    New trial
    |
    Zepsun (donafenib)
    3ms
    Donafenib monotherapy or combined with PD-1/L1 inhibitors or transcatheter arterial chemoembolization as adjuvant therapy in hepatocellular carcinoma patients with high-risk recurrence after radical resection, a multi-cohort clinical study. (ChiCTR2500112389)
    P=N/A, N=90, Recruiting, The First Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Harbin Medical University
    New trial
    |
    AFP (Alpha-fetoprotein)
    |
    Zepsun (donafenib)
    3ms
    Exploratory Clinical Study of TACE Combined with Iparomlimab and Tuvonralimab and Donafenib in Conversion Therapy for Unresectable Locally Advanced and Advanced Hepatocellular Carcinoma (ChiCTR2500112149)
    P=N/A, N=42, Not yet recruiting, The First Affiliated Hospital of University of science and technology of China; The First Affiliated Hospital of University of science and technology
    New trial
    |
    Qibeian (iparomlimab/tuvonralimab) • Zepsun (donafenib) • iparomlimab (QL1604)