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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:
    7d
    A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions (clinicaltrials.gov)
    P=N/A, N=1000, Active, not recruiting, Harbin Medical University
    New trial • Real-world evidence
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • sorafenib • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • oxaliplatin • Zepsun (donafenib)
    8d
    The Application of Locoregional Therapy Combined With Systemic Therapy in the Perioperative Period of Huge Hepatocellular Carcinoma: A Retrospective Cohort Study (clinicaltrials.gov)
    P=N/A, N=715, Completed, Tongji Hospital
    New trial
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • sorafenib • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib) • Stivarga (regorafenib) • Zepsun (donafenib)
    18d
    DosinTACE: Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=48, Active, not recruiting, Nanfang Hospital, Southern Medical University | Not yet recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Mar 2026
    Enrollment closed • Trial primary completion date
    |
    Tyvyt (sintilimab) • Zepsun (donafenib)
    1m
    The DoHAICs Study Expansion Phase (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Tyvyt (sintilimab) • oxaliplatin • Zepsun (donafenib)
    2ms
    Efficacy and safety of transarterial chemoembolization plus donafenib with or without camrelizumab for unresectable hepatocellular carcinoma: a propensity score matching analysis. (PubMed, Front Immunol)
    Although the TACE+D+C group exhibited immune-related adverse events (irAEs) (e.g., hypothyroidism and reactive cutaneous capillary endothelial proliferation), no significant differences were observed between the two groups in drug-related TRAEs, TRAEs after TACE, or Grade 3 TRAEs. The TACE+D+C group significantly improves ORR, PFS and OS in uHCC patients with a comparable safety profile to the TACE+D group, while the single-center retrospective design limits generalizability, warranting prospective studies.
    Retrospective data • Journal
    |
    AFP (Alpha-fetoprotein)
    |
    AiRuiKa (camrelizumab) • Zepsun (donafenib)
    2ms
    A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors (clinicaltrials.gov)
    P1/2, N=15, Terminated, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | N=42 --> 15 | Recruiting --> Terminated; Due to R&D strategy adjustments; no safety issues involved.
    Enrollment change • Trial termination
    |
    erfonrilimab (KN046) • Zepsun (donafenib)
    2ms
    A Single arm, phase II clinical study of QL1706 combined with Donafenib and hepatic arterial infusion chemotherapy (HAIC) as first-line treatment for unresectable biliary malignant tumors (ChiCTR2600120479)
    P2, N=32, Recruiting, Fujian Cancer Hospital; Fujian Cancer Hospital
    New P2 trial
    |
    Qibeian (iparomlimab/tuvonralimab) • Zepsun (donafenib)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    4ms
    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)