A Phase 2 interventional study of Fruquintinib in Hepatocellular Carcinoma, Immune Checkpoint Inhibitors and Anti-angiogenic Therapy, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
3,251 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's planned enrollment of 36 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Sun Yat-sen University is the lead sponsor of 1,681 studies on the registry; 610 are open to participants now.
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Exclusion Criteria:
Fruquintinib monotherapy
Drug: Fruquintinib
Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.
ORR
Objective response rate
Time frame: Two years
OS
Median overall survival
Time frame: Two years
PFS
Median progression-free survival
Time frame: Two years
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Dec 2025, 11 months after the start.
Of 328 non-industry phase 2 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 74. This study's planned 11 months is below that.
Counting every sponsor, half of 404 studies reached it within 44 months; a quarter within 31 and three quarters within 70.
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Studies of the drug tested here: HMPL-013