Cabozantinib for Patients with Hepatocellular Carcinoma (HCC) Refractory to First Line Treatment

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT04511455
Phase
PHASE2
Status
Completed

Conditions

  • Hepatocellular Carcinoma Non-resectable
  • Metastatic Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Dec 8, 2020
Status verified
Jan 2025
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Experimental
    Cabozantinib peroral 60 mg/day A stepwise dose de-escalation schedule on individual level is available for patients with lower tolerability against cabozantinib. The study treatment will be limited to a maximum of 12 months (including interruptions).

Primary Outcome Measure

Time-on-treatment [ Time Frame: at study end (approx. 30 months after FPI) ]

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