NCT04511455

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

A Phase II, Non-randomized, Single Arm, Translational Study of Cabozantinib for Patients with Hepatocellular Carcinoma (HCC) Refractory to First Line Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 proven or were clinically diagnosed (by guideline criteria in cirrhotic patients) with locally advanced or metastatic and/or unresectable HCC will be included to receive 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 temporary interruptions). Tumor tissue will be collected for accompanying research project. (Participation is optional for participant). During treatment, clinical visits (blood cell counts, ECG, detection of toxicity) occur every four weeks during treatment phase. Safety will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. During treatment, tumor response will be assessed by the Investigator according to RECIST 1.1 (radiological imaging by CT and/or MRI of the chest, abdomen, pelvis and all other sites of disease every 10 weeks until end of treatment (EOT) and every 12 weeks during follow-up (FU), in case of EOT due to other reasons than progressive disease. Safety-FU visit and Survival FU visits will be assessed 30 days-, and every 12 weeks after EOT.

Conditions

• Hepatocellular Carcinoma Non-resectable
• Metastatic Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	Cabozantinib 60 mg/day peroral

Timeline

• Start date: 2020-12-08
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-08-13
• Last updated: 2025-01-30

Locations

10 sites across 1 country: Germany