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A Phase II Study of Maintenance Zanzalintinib and Durvalumab in Patients With Advanced Hepatocellular Cancer After Induction Tremelimumab Plus Durvalumab
This research study is for people who were treated with tremelimumab and durvalumab for advanced liver cancer and who are currently receiving durvalumab. Participants in this study will receive a drug called zanzalintinib. They will also continue receiving durvalumab. Studies have shown that patients with advanced liver cancer who had tremelimumab and durvalumab may benefit from taking zanzalintinib while they are taking durvalumab. Zanzalintinib is an investigational drug. This means it has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced liver cancer. Durvalumab is approved by the FDA for patients with advanced liver cancer. The purpose of this study is to find out if taking zanzalintinib with durvalumab will improve how long people with advanced liver cancer will live.
Hepatocellular carcinoma (HCC) (liver cancer) is the third most common cause of cancer-related deaths in the world. In 2020, there were over 900,000 new HCC cases and about 830,000 deaths. For early stages, surgery and liver transplantation can sometimes cure the disease. However, most people with HCC are diagnosed in later, advanced stages of the disease, where systemic (whole body) treatment is the only option. Even with these systemic treatment options, median overall survival is still less than 2 years. Zanzalintinib is an oral drug that targets kinases, which are proteins that help cancer cells grow. It has been shown to work against HCC cancer cells. Researchers hypothesize that the combination of zanzalintinib and durvalumab may help to increase overall survival for people with advanced HCC.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
February 1, 2026
Primary Completion Date
February 1, 2027
Completion Date
August 1, 2027
Last Updated
November 10, 2025
16
ESTIMATED participants
Durvalumab
DRUG
Zanzalintinib
DRUG
Lead Sponsor
Amit Mahipal
Collaborators
NCT06811116
NCT06066138
Data Source & Attribution
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