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Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma

NCT04435977 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-06-17

No results posted yet for this study

Summary

This is an open-label, single-center, Phase II trial designed to estimate in terms of PFS the efficacy of cabozantinib, given as second- or third- line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 antibodies.

Conditions

  • Hepatocarcinoma

Interventions

DRUG

Cabozantinib 60 MG

• The assigned dose for study treatment is 60 mg qd. Two dose reductions will be permitted (Table 2): * 60 mg qd to 40 mg qd (level 1) * 40 mg qd to 20 mg qd (level 2)

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Lorenza Rimassa, MD · Istituto Clinico Humanitas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2023-06-30
Completion
2023-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435977 on ClinicalTrials.gov