Cabozantinib in Patients With Hepatocellular Carcinoma (ACTION)
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
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.