RecruitingPhase 2NCT06446154

Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma

Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study


Sponsor

Sun Yat-sen University

Enrollment

36 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fruquintinib — an oral targeted therapy that blocks new blood vessel growth feeding tumors — can be effective in patients with liver cancer (hepatocellular carcinoma) that cannot be removed by surgery and has already been treated with immune checkpoint inhibitors. **You may be eligible if...** - You are 18 or older with confirmed inoperable or metastatic liver cancer - You have already received immune checkpoint inhibitor treatment - You have at least one measurable tumor on scans - You are in good health (ECOG 0–1) with a liver function score of 7 or below - Your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - You have HIV or have had an organ transplant - You have another active cancer - Your liver is decompensated (severe liver failure) or you have active bleeding - You are allergic to the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFruquintinib

Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.


Locations(1)

Sun Yat-sen university cancer center

Guangzhou, Guangdong, China

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NCT06446154


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