Study of Tocilizumab in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transarterial Chemoembolization (TACE)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT02997956
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Participants will receive Tocilizumab (ACTEMRA®) at 4, 6, or 8 mg/kg IV dose escalation on days 1, 29 and 57.
  • Transcatheter Arterial Chemoembolization — PROCEDURE
    Minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply

Study Details

This is a phase IB study design planned to identify the MTD (Maximum Tolerated Dose) of Tocilizumab in HCC (Hepatocellular Carcinoma) patients followed by a phase II design whereupon the primary objective will be median progression free survival (PFS).

Key Dates

First listed
Dec 20, 2016
Start date
Jul 31, 2017
Status verified
Apr 2017
Primary completion
Jul 31, 2020
Completion
Jul 31, 2022

Study Design

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

Arms

  • Experimental: Tocilizumab
    Participants will receive Tocilizumab (ACTEMRA®) at 4, 6, or 8 mg/kg IV dose escalation on days 1, 29 and 57. The first part of the trial will be Phase Ib and will enroll 18 participants. Participants will receive TACE on day 1 and Tocilizumab at dose level 1, 2, or 3 on days 1, 29 and 57. Maximum tolerated dose (MTD) of Tocilizumab will be determined. The second part of the trial will be a Phase II and will enroll 50 subjects. Participants will receive TACE on day 1 and Tocilizumab at the MTD on days 1, 29 and 57.

Primary Outcome Measure

Maximum Tolerated Dose of Tocilizumab [ Time Frame: 84 Days Post Treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-

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By research site
The University of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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