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Study identifier: NCT06446154 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma

Condition: Hepatocellular Carcinoma · Immune Checkpoint Inhibitors · Anti-angiogenic Therapy  ·  Sponsor: Sun Yat-sen University

PhasePhase 2
Planned participants36
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Ming Shi  ·  020-87343115  ·  shiming@sysu.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Sun Yat-sen university cancer centerGuangzhou, Guangdong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06446154