Health TrialsbyHealthPanel

Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

ConditionsHepatocellular CarcinomaRecurrent CancerLiver Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients.

Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors.

All participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have histologically or cytologically confirmed hepatocellular carcinoma that has recurred.

Previously underwent a liver transplant as a curative treatment for hepatocellular carcinoma (HCC).

Not amenable to curative surgery or local treatment for recurrent disease.

Must have measurable disease.

Disqualifiers

Had systemic therapy or radiotherapy <3 weeks.

Receiving any other investigational agents.

With known brain metastases unless stable for >3 months.

History of allergic reactions attributed to cabozantinib.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cabozantinib

    Drug

    Cabozantinib is a multi-tyrosine kinase inhibitor with activity against VEGFR 1,2,3, MET and AXL, as well as RET, KIT, ant FLT-3.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: CabozantinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease control rate

Proportion of patients with complete response + partial response + stable disease.

Time frame
4 months

Secondary outcomes

1

Progression-free survival

Duration of time from start of treatment to time of progression.

Time frame
3 years
2

Overall survival

Duration of time from start of treatment to time of death.

Time frame
3 years
3

Number of Side Effects Reported

Duration of time from start of trial until end

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Ipsen

Collaborator

Source ClinicalTrials.gov
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