NCT07226063

Maintenance Zanzalintinib and Durvalumab in Participants With Advanced Hepatocellular Cancer

A Phase II Study of Maintenance Zanzalintinib and Durvalumab in Patients With Advanced Hepatocellular Cancer After Induction Tremelimumab Plus Durvalumab

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Amit Mahipal · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma
• Liver Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Participants will receive 1500 mg durvalumab through intravenous (IV) administration over a period of 60 minutes on Day 1 of each 28-day cycle.
DRUG	Zanzalintinib	Participants will receive 60 mg durvalumab orally on Days 1-28 of each 28-day cycle.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2025-11-10
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study