^
    5d
    GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma (clinicaltrials.gov)
    P2, N=93, Recruiting, Fudan University | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial primary completion date
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    gemcitabine • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Zepsun (donafenib)
    13d
    CHANCE 2203: HAIC Combined With Donafenib and Sintilimab for Unresectable ICC (clinicaltrials.gov)
    P2, N=25, Completed, Zhongda Hospital | Recruiting --> Completed | Trial completion date: Jul 2023 --> Oct 2025 | Trial primary completion date: Jun 2023 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date
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    Tyvyt (sintilimab) • oxaliplatin • Zepsun (donafenib)
    25d
    LncRNA ZFAS1 in hepatocellular carcinoma: A systematic review of molecular mechanisms and clinical translation. (PubMed, Noncoding RNA Res)
    Clinically, plasma ZFAS1 demonstrates enhanced diagnostic utility when combined with alpha-fetoprotein (AUC = 0.891), while therapeutic targeting of ZFAS1-mediated PI3K-AKT and PERK/ATF4 pathways shows promise in overcoming sorafenib/donafenib resistance. Current translational challenges include ZFAS1 isoform heterogeneity, suboptimal liquid biopsy sensitivity, and dynamic TME interactions. Future directions should employ multi-omics integration (spatial transcriptomics/single-cell sequencing) coupled with AI-driven network modeling to systematically decode ZFAS1's regulatory architecture, ultimately enabling precision theranostic strategies for HCC management.
    Review • Journal
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    MET (MET proto-oncogene, receptor tyrosine kinase) • AFP (Alpha-fetoprotein) • ATF4 (Activating Transcription Factor 4) • ZEB1 (Zinc Finger E-box Binding Homeobox 1) • AIFM2 (Apoptosis Inducing Factor Mitochondria Associated 2) • MIR150 (MicroRNA 150) • MIR193A (MicroRNA 193a) • MMP14 (Matrix Metallopeptidase 14) • ZFAS1 (ZNFX1 Antisense RNA 1)
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    sorafenib • Zepsun (donafenib)
    30d
    Neo-TACE: Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial. (clinicaltrials.gov)
    P2/3, N=18, Terminated, Peking University | N=156 --> 18 | Trial completion date: Dec 2027 --> Oct 2025 | Recruiting --> Terminated | Trial primary completion date: Dec 2026 --> Oct 2025; Difficult to enroll participants
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    5-fluorouracil • oxaliplatin • leucovorin calcium • Zepsun (donafenib)
    1m
    Case Report: Successful Surgical Resection of PVTT Vp4 Hepatocellular Carcinoma Following Hepatic Arterial Infusion Chemotherapy Combined with Cadonilimab Plus Donafenib. (PubMed, Pharmgenomics Pers Med)
    Following multidisciplinary team evaluation, the patient received conversion therapy consisting of hepatic artery infusion chemotherapy (HAIC) using oxaliplatin, fluorouracil, and leucovorin, in combination with cadonilimab and donafenib...This regimen may substantially improve oncological outcomes and enable curative resection. This case provides compelling evidence to support further clinical investigation of this multimodal therapeutic combination.
    Journal
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    AFP (Alpha-fetoprotein)
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    5-fluorouracil • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab) • Zepsun (donafenib)
    2ms
    AZ-628 sensitizes donafenib in hepatocellular carcinoma by targeting tyrosine kinase pathway and ferroptosis. (PubMed, Cytojournal)
    The HCC cells HepG2 and SNU449 were treated with five drugs, namely, dimethyl sulfoxide, AZ-628, SU-5402, TG-101209, and SPP-86, combined with donafenib to determine half-maximal inhibitory concentration values...Ferrous ion (Fe2+) and reactive oxygen species levels were measured after Erastin/RSL3 induction...In vivo experiments demonstrated a combined anti-tumor efficacy of AZ-628 and donafenib in HCC models (P < 0.0001). The findings of this study reveal a new combination therapy targeting the TK pathway for the treatment of HCC and provide a theoretical foundation for addressing donafenib resistance.
    Journal
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    EGR1 (Early Growth Response 1)
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    AZ 628 • erastin • RSL3 • Zepsun (donafenib) • TG101209
    2ms
    Sequential Transarterial Chemoembolization (TACE), Stereotactic Body Radiation Therapy (SBRT), and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma Treated With Donafenib (clinicaltrials.gov)
    P2, N=34, Not yet recruiting, Jinling Hospital, China
    New P2 trial • Checkpoint inhibition
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    Zepsun (donafenib)
    3ms
    Phase II Study Evaluating the Combination of Linperlisib, Azacitidine, and Liposomal Mitoxantrone in Treatment-Naïve Nodal TFH Cell Lymphoma (ChiCTR2500107944)
    P2, N=30, Not yet recruiting, The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University
    New P2 trial
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    azacitidine • Zepsun (donafenib) • Itari (linperlisib) • Duoenda (mitoxantrone liposomal)
    3ms
    A randomized controlled clinical study on the efficacy and safety of combination/non combination of Donafenib and PD-1 monoclonal antibody with hepatic arterial infusion chemotherapy as first-line treatment for non-surgical hepatocellular carcinoma (ChiCTR2500109530)
    P=N/A, N=78, Recruiting, Fujian Cancer Hospital; Fujian Cancer Hospital
    New trial
    |
    Zepsun (donafenib)
    5ms
    Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Zepsun (donafenib)
    5ms
    Cooperative targeting of NF-κB enhances ferroptosis-driven HCC therapy with Alisertib and Donafenib. (PubMed, Front Cell Dev Biol)
    This suggests a novel combinatorial strategy that targets ferroptosis through NF-κB inhibition. Further research is needed to translate these promising results into clinical practice.
    Journal
    |
    AURKA (Aurora kinase A) • NFKBIA (NFKB Inhibitor Alpha 2)
    |
    alisertib (MLN8237) • Zepsun (donafenib)
    6ms
    Clinical study on the efficacy and safety of donafenib combined with tegine as adjuvant therapy after radical resection of biliary malignant tumors (ChiCTR2500106597)
    P=N/A, N=30, Not yet recruiting, Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University
    New trial
    |
    Teysuno (gimeracil/oteracil/tegafur) • Zepsun (donafenib)