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

Sponsor
Chulalongkorn University
Study ID
NCT06535737
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Cabozantinib (Cabometyx) 60, 40 and 20 mg

Study Details

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.

Key Dates

Start date
Aug 31, 2024
Status verified
Jul 2024
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cabozantinib
    Open-labelled

Primary Outcome Measure

Disease control rate (DCR) per RECIST 1.1 at 4th month [ Time Frame: 4th month of treatment ]

Central Contacts

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