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Donafenib versus sorafenib in triple therapy for unresectable hepatocellular carcinoma: a propensity score-matched
Yaohong Wen1, Shuyi Zhou2, Yuyan Xu1
1General Surgery Center, Department of Hepatobiliary Surgery II, Zhujiang Hospital, Southern Medical University, No.253 Gongye Dadao Zhong, Haizhu District, Guangzhou, 510280, Guangdong Province, China.
Background:
In recent years, triple therapy (molecular targeted agent + PD-1 inhibitor + transarterial therapy) has emerged as a promising strategy for unresectable hepatocellular carcinoma (uHCC). However, the optimal molecular targeted agent choice within triple therapy remains unclear. Donafenib is currently the only targeted drug with superior survival benefits compared with sorafenib monotherapy. This study aimed to compare donafenib-based versus sorafenib-based triple therapy in patients with uHCC, providing preliminary evidence to guide molecular targeted agent selection in this emerging treatment paradigm.
Methods:
This retrospective study enrolled 106 patients with initially uHCC who received triple therapy combining either donafenib or sorafenib with PD-1 inhibitors and transarterial therapies. A 1:2 nearest neighbour propensity score matching was used to minimize selection bias. The primary endpoints were overall survival (OS) and progression-free survival (PFS) based on Kaplan-Meier analysis. The secondary endpoints included objective response rate (ORR), surgical conversion rate and adverse events (AEs). Statistical comparisons used Cox regression for survival data and chi-squared/ t-tests for other metrics, with p < 0.05 indicating significance.
Results:
After matching, 30 patients received sorafenib-based triple therapy (Sor-P-T/H group) and 50 patients received donafenib-based triple therapy (Don-P-T/H group). Although the median OS was not attained, the Don-P-T/H regimen demonstrated a statistically significant survival advantage (HR = 0.317, P = 0.004). Moreover, the Don-P-T/H group demonstrated significantly higher median PFS (9.00 vs. 4.62 months, P = 0.005), ORR (64% vs. 40%, P = 0.037) and surgical conversion rate (26.0% vs. 3.3%, P = 0.01) compared to the Sor-P-T/H group. The two groups showed no notable difference in the overall severity of adverse events but the Don-P-T/H group demonstrated less liver impairment.
Conclusion:
Donafenib may be more advantageous than sorafenib in triple therapy for patients with uHCC.
Insights
Donafenib-based triple therapy shows improved survival and outcomes for unresectable hepatocellular carcinoma (uHCC) compared to sorafenib. This combination therapy (molecular targeted agent + PD-1 inhibitor + transarterial therapy) offers a promising treatment strategy.
Area of Science:
- Hepatobiliary Malignancies
- Oncology
- Translational Research
Background:
- Triple therapy (molecular targeted agent + PD-1 inhibitor + transarterial therapy) is a novel strategy for unresectable hepatocellular carcinoma (uHCC).
- Optimal selection of molecular targeted agents in triple therapy for uHCC remains undetermined.
- Donafenib is a targeted drug with demonstrated survival benefits over sorafenib monotherapy.
Purpose of the Study:
- To compare the efficacy and safety of donafenib-based versus sorafenib-based triple therapy in patients with uHCC.
- To provide evidence for guiding molecular targeted agent selection in uHCC treatment paradigms.
Main Methods:
- Retrospective study of 106 patients with initially unresectable HCC receiving triple therapy.
- 1:2 propensity score matching to minimize bias between donafenib-based and sorafenib-based groups.
- Kaplan-Meier analysis for overall survival (OS) and progression-free survival (PFS); Cox regression and chi-squared/t-tests for secondary endpoints.
Main Results:
- Donafenib-based triple therapy showed a significant survival advantage (HR=0.317, P=0.004) over sorafenib-based therapy.
- Higher median PFS (9.00 vs. 4.62 months, P=0.005), objective response rate (64% vs. 40%, P=0.037), and surgical conversion rate (26.0% vs. 3.3%, P=0.01) in the donafenib group.
- Similar overall adverse event severity but less liver impairment observed with donafenib-based therapy.
Conclusions:
- Donafenib-based triple therapy demonstrates superior efficacy compared to sorafenib-based triple therapy for unresectable HCC.
- Donafenib may be a more advantageous molecular targeted agent in this emerging triple therapy regimen.
- Further research can validate these findings and optimize treatment strategies for uHCC.
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