Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC.
As a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor -1/2/3 (VEGFR 1/2/3), fruquintinib had demonstrated a strong antitumor efficacy in colorectal cancer patients who had previously received standard chemotherapy. Compared with placebo, fuquinitinib significantly extended overall survival in patients with metastatic colorectal cancer (median OS, 9.3 months vs 6.6 months; HR, 0.65; p\<0.001) and progression-free survival (median PFS, 3.7 months vs 1.8 months; HR, 0.26; p\<0.001). Additionally, a phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median PFS of 7.4 months and a tumor response rate of 31.6%.
Therefore, we intend to conduct this clinical study to explore the efficacy and safety of fruquintinib as second-line treatment for patients with unresectable HCC previously treated with immune checkpoint inhibitors.
patients aged 18 years or older
with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria
who had previously received immune checkpoint inhibitors
had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria
history of HIV, organ allograft
combined with other malignant tumors
evidence of hepatic decompensation, bleeding diathesis or event
allergy to the investigational agents or any agent given in association with this trial
Sun Yat-sen University
Lead sponsor
Guangzhou First People's Hospital
Collaborator