Zepsun (donafenib) / Suzhou Zelgen - LARVOL DELTA

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 • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Thrombosis • AFP

Efficacy and safety analysis of donafenib combined with PD-1 inhibitors with or without chemotherapy in patients with advanced BTC: A retrospective study (ESMO Asia 2025) - "Donafenib and anti-PD-1 antibodies with or without Chemotherapy as a 1L treatment option for advanced BTC patients shows favorable efficacy and tolerability."

Metastases • Retrospective data • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology

Donafenib, anti-PD-1 antibodies, plus HAIC as conversion therapy in patients with initially unresectable HCC:A prospective, single-arm, phase II study (ESMO Asia 2025) - P4 | "The triple combination of donafenib, anti-PD-1 antibodies, and HAIC exhibits favorable efficacy and tolerability, positioning it as a clinically feasible conversion strategy for initially unresectable HCC."

Clinical • P2 data • Hepatocellular Cancer • Oncology

FOLFOX-HAIC combined with sintilimab and donafenib for advanced hepatocellular carcinoma: A single-arm, phase II study (ESMO Asia 2025) - "The combination of mFOLFOX6-HAIC with sintilimab and donafenib exhibited an encouraging short-term efficacy for advanced HCC by improving the ORR and DCR, with acceptable toxicity. We will report more data in the future."

Metastases • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor

Adjuvant donafenib combined with PD-1 for hepatocellular carcinoma with high-risk recurrence factors after radical resection: A sIPTW adjusted retrospective cohort study (Adhere study) (ESMO Asia 2025) - "Adjuvant donafenib combined with PD-1 could improve RFS compared to active surveillance in Chinese HCC patients with high-risk recurrence factors after radical resection."

Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor • PD-1

Donafenib and sintilimab plus transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: A phase II, biomarker exploratory study (DosinTACE). (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT05507632 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Biomarker • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

TACE-HAlC combined with Donafenib and immune checkpoint inhibitors for BCLC stage C HCC patients (THEME study): a retrospective IPTW-adjusted cohort study. (PubMed, Front Immunol) - "Among these the incidence of grade ≥3 AE was 40.8% in the quadruple therapy group and 38.6% in the targeted-immunotherapy group. Compared with targeted-immunotherapy group, patients with BCLC stage C HCC treated with TACE-HAIC combined with donafenib and ICIs demonstrated superior efficacy and acceptable safety."

Checkpoint inhibition • Journal • Retrospective data • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Correction: TACE-HAlC combined with Donafenib and immune checkpoint inhibitors for BCLC stage C HCC patients (THEME study): a retrospective IPTW-adjusted cohort study. (PubMed, Front Immunol) - "[This corrects the article DOI: 10.3389/fimmu.2025.1669856.]."

Checkpoint inhibition • Journal • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

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 • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • EGR1

Development of an UPLC-MS/MS method for quantification of donafenib and its metabolite in rat plasma: application to drug-drug interaction. (PubMed, Biochem Pharmacol) - "In vivo, the AUC(0-t), AUC(0-∞) and Cmax of donafenib and donafenib N-oxide were significantly increased in the presence of efavirenz, which indicated that efavirenz increased the exposure of donafenib in rats. In short, this UPLC-MS/MS method was reliable for quantifying donafenib and its metabolite, and the findings suggested that efavirenz had an inhibitory effect on the metabolism of donafenib in vitro and in vivo."

Journal • Preclinical • Hepatocellular Cancer • Human Immunodeficiency Virus • Infectious Disease • Oncology • Solid Tumor

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 | Sponsor: Jinling Hospital, China

Checkpoint inhibition • New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Phase II Study Evaluating the Combination of Linperlisib, Azacitidine, and Liposomal Mitoxantrone in Treatment-Naïve Nodal TFH Cell Lymphoma (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

New P2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Efficacy and safety of DEB-TACE combined with HAIC and donafenib in the treatment of unresectable hepatocellular carcinoma: a dual-center retrospective study. (PubMed, BMC Cancer) - "Compared with DEB-TACE combined with donafenib, the combination of DEB-TACE, HAIC, and donafenib demonstrated superior tumor control and survival benefit in patients with uHCC, with an acceptable safety profile. Further prospective randomized controlled trials are warranted to validate the long-term efficacy and safety of this combination strategy."

Journal • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

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 (ChiCTR) - P=N/A | N=78 | Recruiting | Sponsor: Fujian Cancer Hospital; Fujian Cancer Hospital

New trial • Hepatocellular Cancer • Oncology • Solid Tumor

Analysis of common treatment-related adverse events of donafenib and its correlation with efficacy: exploratory analysis of the ZGDH3 study. (PubMed, Eur J Med Res) - P2/3 | "The occurrence of HFSR, diarrhea, thrombocytopenia, hypertension, alopecia, rash, proteinuria, fatigue, and Grade ≥ 3 increased blood bilirubin may be associated with the efficacy of donafenib in the treatment of advanced HCC, though these are exploratory associations and not established predictive markers. The AEs associated with donafenib are generally well tolerated, though further validation is needed."

Adverse events • Journal • Retrospective data • Alopecia • Cardiovascular • Fatigue • Hematological Disorders • Hepatocellular Cancer • Hypertension • Immunology • Oncology • Renal Disease • Solid Tumor • Thrombocytopenia

The efficacy and safety analysis of D-TACE combined with donafenib and tislelizumab in recurrent hepatocellular carcinoma after surgery. (PubMed, Sci Rep) - "While hypothyroidism incidence was higher in the D-TACE + Donafenib + Tislelizumab group (21.6% vs. 7.4%, P = 0.051), the D-TACE + Sorafenib group exhibited increased fatigue (35.2% vs. 11.8%, P = 0.006) and anorexia (35.2% vs. 13.7%, P = 0.013). These findings suggest that D-TACE combined with Donafenib and Tislelizumab offers superior tumor control and survival benefits with a manageable safety profile, representing a promising therapeutic strategy for postoperative recurrent HCC."

Journal • Retrospective data • Anorexia • Endocrine Disorders • Fatigue • Hepatocellular Cancer • Oncology • Solid Tumor

The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study (clinicaltrials.gov) - P=N/A | N=118 | Not yet recruiting | Sponsor: Xuhua Duan

New trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Efficacy and liver function preservation with donafenib combined with transarterial chemoembolization in unresectable hepatocellular carcinoma: An ALBI grade analysis. (PubMed, Front Oncol) - "The combination of donafenib and TACE demonstrates favorable hepatic function preservation while maintaining therapeutic efficacy. ALBI grade improvement is correlated with enhanced treatment response and survival outcomes, indicating potential synergistic benefits for tumor control and hepatic function preservation."

IO biomarker • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Triple Therapy with Interventional Treatment, Donafenib, and Anti-PD-1 Antibodies in Unresectable Hepatocellular Carcinoma: A Retrospective Real-World Study in China. (PubMed, J Hepatocell Carcinoma) - "This retrospective study included 89 patients with uHCC who received donafenib, anti-PD-1 monoclonal antibodies (tislelizumab or sintilimab), and interventional therapies (TACE and/or HAIC) between March 2022 and December 2023. Grade ≥3 treatment-related adverse events occurred in 30.3% of patients; no treatment-related deaths were reported. The combination of interventional therapies, donafenib, and anti-PD-1 monoclonal antibodies demonstrated promising efficacy and manageable safety in uHCC, warranting further validation in prospective trials."

Journal • Real-world evidence • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

Donafenib vs. lenvatinib combined with transarterial chemoembolization as initial therapy for unresectable hepatocellular carcinoma: a retrospective real-world study. (PubMed, Quant Imaging Med Surg) - "Dona-TACE and LEN-TACE demonstrated comparable efficacy in unresectable HCC, but Dona-TACE exhibited a superior safety profile, suggesting its potential as a preferable option for patients with higher comorbidity risks. Further prospective studies are warranted to validate these findings."

Journal • Real-world evidence • Retrospective data • Cardiovascular • Hepatitis B • Hepatocellular Cancer • Hypertension • Infectious Disease • Oncology • Solid Tumor

Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

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 • Hematological Disorders • Hepatocellular Cancer • Oncology • Solid Tumor • AURKA • NFKBIA

Efficacy and Liver Function Preservation with Donafenib Combined with Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma: An ALBI grade Analysis (Frontiers) - "Our prospective analysis demonstrated significant antitumor efficacy with favorable hepatic safety. The regimen achieved objective response and disease control rates of 69.4% and 91.7%, respectively, with median progression-free survival of 10.7 months and median time to response of 1.4 months, indicating rapid therapeutic onset. Hepatic function remained stable throughout treatment, with consistent ALBI grades from baseline to progression/final follow-up (-2.41±0.41 vs. -2.45±0.52, P=0.67). Among patients, 58.3% maintained stable hepatic function, while 25.0% improved from ALBI grade 2 to 1."

Real-world • Hepatocellular Cancer

Clinical study on the efficacy and safety of donafenib combined with tegine as adjuvant therapy after radical resection of biliary malignant tumors (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University

New trial • Biliary Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

A prospective, single-arm clinical study on the efficacy and safety of Donafenib combined with Tislelizumab and hepatic arterial infusion chemotherapy (HAIC) as first-line treatment for BCLC stage B/C hepatocellular carcinoma. (ChiCTR) - P=N/A | N=56 | Recruiting | Sponsor: Maoming People's Hospital; Maoming People's Hospital

New trial • Hepatocellular Cancer • Oncology • Solid Tumor