Cabozantinib in Patients With Hepatocellular Carcinoma (ACTION)

Sponsor
Fundacion Clinic per a la Recerca Biomédica
Study ID
NCT04316182
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    Cabozantinib 60 mg/day. Cabozantinib dose will be modified upon development of adverse events.

Study Details

Cabozantinib, a small molecule directed to vascular endothelial growth factor receptors, MET and AXL, has shown to significantly improve the overall survival (OS) over placebo in the randomized phase 3 CELESTIAL trial in patients who had up to two lines of prior systemic therapy (including sorafenib) with progression on at least one in comparison to patients who received best supportive care. Although cabozantinib shares similar targets with sorafenib/regorafenib, they present different toxicity profile. While the most common grade 3-4 Adverse Events reported for sorafenib were fatigue (4%), diarrhea (8%), hand-foot reaction (8%) and hypertension (2%); the most frequent grade 3-4 Adverse Events for cabozantinib were hand-foot reaction (3.6%), hypertension (3.4%) and elevation of AST (2.6%). In clinical practice, regorafenib, ramucirumab and cabozantinib are approved by European Medicines Agency (EMA) as second-line treatment approved by EMA until now. However, more than 40% of candidate patients to 2nd line do not meet the RESORCE criteria or REACH-2 trial and are only candidates to cabozantinib treatment. However, investigators do not have safety data about those patients who are treated with other treatments than sorafenib in first line neither data about the real impact of sorafenib-intolerant patients according to the RESORCE trial definition. For this reason, investigators propose to explore the role of cabozantinib in patients who were not considered in the CELESTIAL trial.

Key Dates

Start date
Jul 31, 2020
Status verified
Mar 2025
Primary completion
Feb 22, 2023
Completion
Feb 22, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Cabozantinib at 60 mg/day in monotherapy until symptomatic tumor progression, unacceptable adverse events, patient decision or death

Primary Outcome Measure

Rate of Adverse Events (AE) ≥ Grade 3 (CTCAE 5.0) Excluding Palmar-plantar Erythrodysesthesia [ Time Frame: Up to 18 months ]

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