Cabozantinib in Patients With Hepatocellular Carcinoma (ACTION) (ACTION)
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|ClinicalTrials.gov Identifier: NCT04316182|
Recruitment Status : Active, not recruiting
First Posted : March 20, 2020
Last Update Posted : July 8, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Cabozantinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II triAl of Cabozantinib for hepaTocellular carcInoma Patients intOlerant to Sorafenib Treatment or First Line Treatment Different to sorafeNib. (ACTION Trial)|
|Actual Study Start Date :||July 31, 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Cabozantinib at 60 mg/day in monotherapy until symptomatic tumor progression, unacceptable adverse events, patient decision or death
Cabozantinib 60 mg/day. Cabozantinib dose will be modified upon development of adverse events.
Other Name: Cabometix
- Rate of adverse events (AE) ≥ grade 3 (CTCAE 5.0) excluding palmar-plantar erythrodysesthesia [ Time Frame: Up to 18 months ]Percentage of patients with Grade 3 AEs in relation with total number of treated patients
- Rate of adverse events [ Time Frame: Up to 18 months ]Percentage of patients with AEs in relation with total number of treated patients
- Rate of related-AEs [ Time Frame: Up to 18 months ]Percentage of patients with related AEs in relation with total number of treated patients
- Rate of death [ Time Frame: Up to 18 months ]Percentage of patients who die during treatment in relation with total number of treated patients
- Rate of AEs leading to treatment discontinuation [ Time Frame: Up to 18 months ]Percentage of patients with AEs leading to treatment discontinuation in relation with total number of treated patients
- Time to progression (TTP) [ Time Frame: Up to 18 months ]Time from the date of start of treatment until the date of objective disease progression or death
- Objective response rate (ORR) [ Time Frame: Up to 18 months ]ORR is defined as the number of subjects with a best overall response of a complete response (CR) or partial response (PR) divided by the number of included patients
- Pattern of progression [ Time Frame: Up to 18 months ]Type of progression divided by number of patients
- Overall survival (OS) [ Time Frame: Up to 18 months ]Time from the date of start of treatment until the date of death
- Post-progression survival (PPS) [ Time Frame: Up to 18 months ]Time from the date of disease progression until the date of death
- Rate of patients who develop new extra-hepatic spread [ Time Frame: Up to 18 months ]Number of subjects who develop new extra-hepatic spread divided by number of included patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316182
|Hospital Vall d'Hebron|
|Institut Català D'Oncologia - Hospital Duran I Reynals|
|Hospital Puerta de Hierro|
|Hospital Ramon y Cajal|
|Hospital Central de Asturias|
|Principal Investigator:||Maria Reig, MD||BCLC group. Liver Unit. Hospital Clinic. Ciberehd|