Cabozantinib for Patients with Hepatocellular Carcinoma (HCC) Refractory to First Line Treatment (NCT04511455) | Clinical Trial Compass
CompletedPhase 2
Cabozantinib for Patients with Hepatocellular Carcinoma (HCC) Refractory to First Line Treatment
Germany22 participantsStarted 2020-12-08
Plain-language 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 progressed either during lenvatinib monotherapy or lenvatinib-IO (immuno-oncology) combination therapy will be eligible for study participation, whereas at least 50% of the enrolled patients should be in favor of lenvatinib monotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Fully-informed written consent.
✓. Males and females ≥ 18 years of age.
✓. 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 criteria
✕. 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.
What they're measuring
1
Time-on-treatment
Timeframe: at study end (approx. 30 months after FPI)
Trial details
NCT IDNCT04511455
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest