Status:
COMPLETED
Cabozantinib for Patients with Hepatocellular Carcinoma (HCC) Refractory to First Line Treatment
Lead Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborating Sponsors:
Ipsen
Conditions:
Hepatocellular Carcinoma Non-resectable
Metastatic Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients suffering from advanced stage hepatocellular carcinoma (HCC) who have shown disease progression during lenvatinib-based first line treatment, will be enrolled in this trial. Patients who prog...
Detailed Description
This is a open-label, single-arm, multicenter phase II trial for patients with locally advanced and/or metastatic and/or unresectable hepatocellular carcinoma (HCC). Patients who have histologically ...
Eligibility Criteria
Inclusion
- Fully-informed written consent.
- Males and females ≥ 18 years of age.
- \*There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently.
- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by guideline criteria in cirrhotic patients
- Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.
- Patients who have shown progressive disease during or after first line therapy OR patients must have had their treatment interrupted due to the level of toxicities AND cabozantinib therapy is intended as second line therapy.
- ECOG performance status ≤ 2.
- Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade 1 prior to study entry, with the exception of alopecia.
- For women of childbearing potential and men who are sexually active with women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods.
Exclusion
- Unwillingness to give informed consent for participation in the study.
- Prior sorafenib treatment.
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after last dose of study treatment.
- Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
- Significant portal hypertension (moderate or severe ascites).
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Liver cirrhosis Child-Pugh B with \> 7 points and Child-Pugh C.
- Severely impaired kidney function.
- History of encephalopathy in past 12 months, if not completely regressive or more than one episode within the last 6 months.
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
- Baseline QTcF \>500 ms.
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
- Elevations of AST/ALT exceeding 5 X ULN.
- Treatment with investigational systemic therapy within 28 days prior to initiation of study treatment.
- Prior cabozantinib use.
- Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \[§ 40 Abs. 1 S. 3 Nr. 3a AMG\].
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04511455
Start Date
December 8 2020
End Date
December 31 2024
Last Update
January 30 2025
Active Locations (10)
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1
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526
2
Universitätsklinikum Köln
Cologne, Germany, 50937
3
Universitätsklinikum Halle (Saale)
Halle, Germany, 06120
4
Medizinische Hochschule Hannover
Hanover, Germany, 30625