Fruquintinib for Unresectable Hepatocellular Carcinoma Previously Treated with Immune Checkpoint Inhibitors A Single-Arm Phase II Study

What this Trial Is About

Researchers are investigating a new second-line treatment for advanced hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. This phase II clinical study aims to evaluate the effectiveness and safety of fruquintinib, a drug that targets blood vessel growth in tumors. Fruquintinib has previously shown strong anti-cancer effects in colorectal cancer and promising results when combined with another drug in advanced HCC patients who have already received standard treatments. In this study, participants will receive fruquintinib alone, taken orally at a dose of 5 mg daily for three weeks, followed by one week without the drug. This treatment cycle will repeat as part of the study to assess how fruquintinib works as a second-line option after prior immune checkpoint inhibitor therapy. The study is non-randomized and open-label, meaning all participants will receive the study drug without placebo. During the trial, researchers will monitor participants for tumor response, overall survival, and progression-free survival over two years. Participants will undergo regular assessments to measure these outcomes along with evaluations of liver function, blood counts, and heart function to ensure safety. The study will follow participants for up to two years to understand the long-term effects and potential benefits of fruquintinib in advanced HCC.

Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma