^
3d
New P4 trial
|
capecitabine • Zepsun (donafenib)
4d
New trial • Metastases
|
Herceptin (trastuzumab) • Zepsun (donafenib)
4d
New trial • Real-world evidence • Real-world
|
Zepsun (donafenib)
4d
Donafenib Combined with 131I for the Treatment of Postoperative Recurrent/Metastatic Differentiated Thyroid Cancer Patients: A Single-Center, Single-Arm, Prospective Phase II Clinical Study (ChiCTR2400089560)
P2, N=13, Recruiting, The First Affiliated Hospital with Nanjing Medical University; The First Affiliated Hospital with Nanjing Medical University
New P2 trial • Metastases
|
Zepsun (donafenib)
1m
New trial • Combination therapy • Checkpoint inhibition • Metastases
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • sorafenib • 5-fluorouracil • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib) • Zepsun (donafenib)
2ms
New trial
|
Zepsun (donafenib)
2ms
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma (clinicaltrials.gov)
P=N/A, N=204, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
New trial
|
Zepsun (donafenib)
3ms
Efficacy and safety of hepatic arterial infusion chemotherapy combined with donafenib in the treatment of unresectable hepatocellular carcinoma. (PubMed, Asia Pac J Clin Oncol)
Donafenib combined with HAIC in the treatment of unresectable HCC patients can notably reduce serum AFP levels, improve hepatic fibrosis, enhance short-term efficacy, prolong PFS, and have a favorable safety profile.
Journal
|
KDR (Kinase insert domain receptor) • AFP (Alpha-fetoprotein) • FASLG (Fas ligand) • CASP3 (Caspase 3) • FAS (Fas cell surface death receptor)
|
Zepsun (donafenib)
3ms
GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma (clinicaltrials.gov)
P2, N=93, Recruiting, Fudan University | N=35 --> 93 | Trial completion date: Mar 2025 --> Mar 2027 | Trial primary completion date: Sep 2024 --> Sep 2026
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
gemcitabine • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Zepsun (donafenib)
3ms
Trial completion • Metastases
|
Zepsun (donafenib)
4ms
Immune effect and prognosis of transcatheter arterial chemoembolization and tyrosine kinase inhibitors therapy in patients with hepatocellular carcinoma. (PubMed, World J Gastrointest Oncol)
TACE, in combination with different TKIs, produces different immune responses. Specifically, TACE combined with donafenib or lenvatinib may induce strong anti-tumor immune responses.
Journal
|
CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)
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sorafenib • Lenvima (lenvatinib) • AiTan (rivoceranib) • Zepsun (donafenib)
4ms
Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=30, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
New P2 trial
|
Tyvyt (sintilimab) • oxaliplatin • Zepsun (donafenib)
4ms
New P2 trial • Combination therapy • Surgery
|
Enweida (envafolimab) • Zepsun (donafenib)
4ms
Small molecule tyrosine kinase inhibitors approved for systemic therapy of advanced hepatocellular carcinoma: recent advances and future perspectives. (PubMed, Discov Oncol)
Currently, a total of six small molecule tyrosine kinase inhibitors (TKIs) have been approved for aHCC, including first-line sorafenib, lenvatinib, and donafenib, and second-line regorafenib, cabozantinib, and apatinib. These TKIs improved patients survival, which are associated with disease stage, etiology, liver function, tumor burden, baseline levels of alpha-fetoprotein, and treatment history. This review focuses on the clinical outcomes of these TKIs in key clinical trials, retrospective and real-world studies and discusses the future perspectives of TKIs for aHCC, with an aim to provide up-to-date evidence for decision-making in the treatment of aHCC.
Review • Journal • Metastases
|
AFP (Alpha-fetoprotein)
|
sorafenib • Lenvima (lenvatinib) • AiTan (rivoceranib) • Cabometyx (cabozantinib tablet) • Stivarga (regorafenib) • Zepsun (donafenib)
5ms
New P2 trial • Metastases
|
Mekinist (trametinib) • Tafinlar (dabrafenib) • Vitrakvi (larotrectinib) • sorafenib • Rozlytrek (entrectinib) • Focus V (anlotinib) • everolimus • Lenvima (lenvatinib) • AiTan (rivoceranib) • Cabometyx (cabozantinib tablet) • Gavreto (pralsetinib) • Caprelsa (vandetanib) • Zepsun (donafenib)
5ms
Donafenib inhibits PARP1 expression and induces DNA damage, in combination with PARP1 inhibitors promotes apoptosis in liver cancer cells. (PubMed, Anticancer Drugs)
These data suggest that the combination of donafenib and a PARP1 inhibitor results in more significant DNA damage in cells and promotes cell apoptosis. Thus, the combination of donafenib and PARP1 inhibitors has the potential to be a treatment option for liver cancer.
Journal • Combination therapy • PARP Biomarker • IO biomarker
|
BAX (BCL2-associated X protein) • H2AX (H2A.X Variant Histone)
|
Zepsun (donafenib)
5ms
A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor (clinicaltrials.gov)
P1/2, N=130, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Zepsun (donafenib) • ZG005
6ms
Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies. (clinicaltrials.gov)
P4, N=53, Recruiting, Fudan University | Trial completion date: Jun 2024 --> Apr 2025 | Trial primary completion date: May 2024 --> Feb 2025
Trial completion date • Trial primary completion date • Adverse events • Metastases
|
sorafenib • Lenvima (lenvatinib) • AiTan (rivoceranib) • Stivarga (regorafenib) • Zepsun (donafenib)
6ms
Assessment of safety and efficacy of transarterial chemoembolization combined with camrelizumab and donafenib in patients with hepatocellular carcinoma at BCLC stage C: A study of 20 cases. (PubMed, Medicine (Baltimore))
Median progression-free survival and overall survival were 9 and 14 months, respectively. TACE, camrelizumab, and donafenib combination therapy in Chinese advanced HCC patients show effectiveness in extending survival with low severe AEs incidence.
Journal
|
PD-1 (Programmed cell death 1)
|
AiRuiKa (camrelizumab) • Zepsun (donafenib)
7ms
Journal
|
RELA (RELA Proto-Oncogene) • ZFAS1 (ZNFX1 Antisense RNA 1)
|
RELA expression
|
Zepsun (donafenib)
7ms
New P1 trial • Real-world evidence • Real-world • Metastases
|
sorafenib • Stivarga (regorafenib) • Zepsun (donafenib)
8ms
Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
P1, N=18, Active, not recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
Loqtorzi (toripalimab-tpzi) • Zepsun (donafenib)
9ms
New trial • Combination therapy
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • sorafenib • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib) • oxaliplatin • Zepsun (donafenib)
9ms
New P2 trial
|
Tyvyt (sintilimab) • oxaliplatin • Zepsun (donafenib)
9ms
New P2 trial
|
Tevimbra (tislelizumab-jsgr) • Zepsun (donafenib)
10ms
A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor (clinicaltrials.gov)
P1/2, N=130, Not yet recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
New P1/2 trial
|
Zepsun (donafenib) • ZG005
10ms
Neo-TACE: Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial. (clinicaltrials.gov)
P2/3, N=156, Recruiting, Peking University | Trial primary completion date: Dec 2023 --> Jun 2024
Trial primary completion date
|
5-fluorouracil • oxaliplatin • leucovorin calcium • Zepsun (donafenib)
11ms
Transarterial chemoembolization combined donafenib with/without PD-1 for unresectable HCC in a multicenter retrospective study. (PubMed, Front Immunol)
No significant differences were found in the incidence or severity of adverse events between the TACE+DP and TACE+D groups (any grade: 92.9% vs. 94.6%, P=0.270; grade 3 or 4: 33.8% vs. 37.3%, P=0.253). With favorable safety and tolerability, TACE combined with donafenib and PD-1 inhibitors significantly improved PFS, OS, and ORR compared to TACE combined with donafenib.
Retrospective data • Journal
|
PD-1 (Programmed cell death 1)
|
Zepsun (donafenib)
11ms
Tinengotinib (TT-00420) in combination with atezolizumab in Chinese patients (pts) with biliary tract carcinoma (BTC): Preliminary efficacy and safety results from a phase Ib/II study. (ASCO-GI 2024)
Clinical Trial Registration Number NCT05253053 Sponsored by No funding sources reported Background: Programmed Cell Death Ligand 1 (PD-L1) inhibitor durvalumab in combination with gemcitabine and cisplatin has been approved as first-line therapy for BTC...Another pt with prior immunotherapy (sintilimab), target therapy (donafenib) and chemotherapy had a tumor reduction of 39.1% (tinengotinib 10 mg QD plus atezo)... Tinengotinib in combination with atezo was well-tolerated for the treatment of Chinese BTC pts. Preliminary encouraging efficacy of tinengotinib in combination with atezo was observed in pts with heavily pre-treated BTC. The ongoing study is to further evaluate the safety and efficacy of tinengotinib in combination with atezo in pts with BTC who had prior immunotherapy and/or chemotherapy.
Clinical • P1/2 data • Combination therapy
|
cisplatin • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • gemcitabine • Tyvyt (sintilimab) • tinengotinib (TT-00420) • Zepsun (donafenib)
12ms
Study of the safety and efficacy of donafenib combined with toripalimab in patients with non-MSI-H metastatic colorectal cancer (ChiCTR2100048891)
P1/2, N=35, Not yet recruiting, Sichuan Cancer Hospital ; Sichuan Cancer Hospital | Phase classification: P=N/A --> P1/2
Phase classification • Metastases
|
MSI (Microsatellite instability)
|
Loqtorzi (toripalimab-tpzi) • Zepsun (donafenib)
1year
URI alleviates tyrosine kinase inhibitors-induced ferroptosis by reprogramming lipid metabolism in p53 wild-type liver cancers. (PubMed, Nat Commun)
The combination of SCD1 inhibitor aramchol and deuterated sorafenib derivative donafenib displays promising anti-tumor effects in p53-wild type HCC patient-derived organoids and xenografted tumors. This combination therapy has potential clinical benefits for the patients with advanced HCC who have wild-type p53 and high levels of URI/SCD1.
Journal
|
SCD (Stearoyl-CoA Desaturase) • TRIM28 (Tripartite Motif Containing 28)
|
TP53 wild-type
|
sorafenib • Zepsun (donafenib) • Aramchol (aramchol meglumine)
1year
Recent advances in treatment strategies for hepatocellular carcinoma with portal vein cancer thrombus. (PubMed, Eur Rev Med Pharmacol Sci)
Systemic treatment with molecularly targeted drugs and immune checkpoint inhibitors, such as sorafenib, lenflutinib, donafenib, atezolizumab plus bevacizumab, sintilimab plus IBI305, regorafenib, pembrolizumab and anti-Cytotoxic T Lymphocyte antigen 4 (CTLA-4) was recommended by guidelines, but with limited effectiveness for HCC patients with PVTT. In recent years, the comprehensive treatment of HCC has advanced greatly. This review aims to provide an insight into the treatment modalities available for HCC patients with PVTT.
Journal
|
Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • sorafenib • Tyvyt (sintilimab) • Stivarga (regorafenib) • Byvasda (bevacizumab biosimilar) • Zepsun (donafenib)
over1year
Donafenib and GSK-J4 Synergistically Induce Ferroptosis in Liver Cancer by Upregulating HMOX1 Expression. (PubMed, Adv Sci (Weinh))
A chromosome conformation capture assay confirmed that the increased expression of HMOX1 is caused by the significantly enhanced interaction between the promoter and upstream enhancer under dual-drug combination. Taken together, this study elucidates a new synergistic lethal interaction in liver cancer.
Journal
|
HMOX1 (Heme Oxygenase 1)
|
HMOX1 expression
|
GSKJ4 • Zepsun (donafenib)
over1year
Multicenter randomized double-blind phase III trial of donafenib in progressive radioactive iodine-refractory differentiated thyroid cancer. (PubMed, Clin Cancer Res)
Donafenib was well-tolerated, and demonstrated clinical benefit in terms of improved PFS, ORR and DCRin patients with RAIR-DTC. The results suggest that donafenib could be a new treatment option for RAIR-DTC patients.
P3 data • Clinical Trial,Phase III • Journal
|
Zepsun (donafenib)
over1year
Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation (clinicaltrials.gov)
P2, N=20, Recruiting, Beijing Tsinghua Chang Gung Hospital | Not yet recruiting --> Recruiting | Initiation date: Oct 2022 --> Mar 2023
Enrollment open • Trial initiation date
|
Zepsun (donafenib)
over1year
Safety and efficacy of GEMOX plus donafenib and tislelizumab as first-line therapy for advanced epithelial malignant biliary tract cancer. (PubMed, Cancer Med)
GEMOX combined with donafenib plus tislelizumab as the first-line therapy for unresectable BTC showed manageable toxicity and encouraging efficacy especially in terms of promising conversion rate in Stage III patients.
Journal • Metastases
|
gemcitabine • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Zepsun (donafenib)
over1year
Lenvatinib in the treatment of unresectable hepatocellular carcinoma: a systematic review of economic evaluations. (PubMed, Eur J Clin Pharmacol)
Lenvatinib was generally cost-effective in most studies, but not compared to donafenib or sorafenib (if the price sorafenib was significantly discounted).
Review • Journal • HEOR
|
sorafenib • Lenvima (lenvatinib) • Zepsun (donafenib)
over1year
Development of a UPLC-MS/MS method for simultaneous therapeutic drug monitoring of anti-hepatocellular carcinoma drugs and analgesics in human plasma. (PubMed, Front Pharmacol)
In hepatocellular carcinoma treatment, sorafenib, oxaliplatin, 5-fluorouracil, capecitabine, lenvatinib, and donafenib are first-line drugs; regorafenib, apatinib, and cabozantinib are second-line drugs; and oxycodone, morphine, and fentanyl are commonly used analgesics...The precision and accuracy of all analytes were < 7.21% and 5.62%, respectively. Our study provides empirical support for a simple, reliable, specific, and suitable technique for clinical TDM and pharmacokinetics.
Journal
|
sorafenib • Lenvima (lenvatinib) • AiTan (rivoceranib) • capecitabine • Cabometyx (cabozantinib tablet) • Stivarga (regorafenib) • oxaliplatin • Zepsun (donafenib)
over1year
A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer (clinicaltrials.gov)
P1b, N=19, Terminated, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting --> Terminated; Corporate policy adjustments
Trial termination • Metastases
|
Zepsun (donafenib)
over1year
CISLD-8: 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, Recruiting, Zhejiang University | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
Trial completion date • Trial primary completion date
|
AFP (Alpha-fetoprotein)
|
Zepsun (donafenib)