NCT06535737

A Phase 2, Single Arm Study of Cabozantinib in Patients With Hepatocellular Carcinoma Who Have Received Prior Atezolizumab and Bevacizumab

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hepatocellular carcinoma (HCC) is the most common liver cancer and a leading cancer death worldwide. Currently, atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC. There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab. Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib. The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab. It is a multi-center single-arm study which all participants will receive cabozantinib. Participants will continue cabozantinib until. disease progression or unacceptable toxicities.

Detailed description

Currently, atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC. There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab. Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib. The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab. This is a phase II, single-arm, multi-center trial which all participants will receive cabozantinib. Eligible patients will provide informed consent to participate the trial. The study will enroll 40 patients. All participants will receive cabozantinib until disease progression or unacceptable toxicities. Efficacy assessment will be performed with CT scan or MRI every 8 weeks. Clinical assessments and laboratory tests will be scheduled every 2-4 weeks for safety assessments.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
DRUG	Cabozantinib	Cabozantinib (Cabometyx) 60, 40 and 20 mg

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-08-02
• Last updated: 2024-08-02