Zepsun (donafenib)

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

P2, N=90, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital

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.

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.

P2, N=32, Recruiting, Fujian Cancer Hospital; Fujian Cancer Hospital

P=N/A, N=941, Completed, Zhongda Hospital | Recruiting --> Completed | N=220 --> 941 | Trial completion date: Sep 2023 --> Sep 2025

P=N/A, N=1244, Completed, Zhongda Hospital | Recruiting --> Completed | N=474 --> 1244

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.

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.

P1, N=30, Completed, Zhejiang University | Recruiting --> Completed | Trial completion date: Jun 2024 --> Nov 2025 | Trial primary completion date: Dec 2023 --> Nov 2025

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.

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.