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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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 facts

Study ID

NCT02997956

Run by

University of Michigan Rogel Cancer Center

People needed

0

Starts

2017-07-01

Expected to finish

2022-07-01

Last updated by the study team

2017-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic evidence of HCC, Barcelona-Clinic Liver Cancer (BCLC) stage B
• FFPE (Fixed-paraffin Embedded) tumor tissue (two cores preferred) for biomarker analysis
• Prior radioembolization, local ablative therapies (radiofrequency, microwave or cryoablation), radiation (external beam or stereotactic), or hepatic resection permitted if completed ≥ 4 weeks prior to study enrollment and if patient has recovered with ≤ grade 1 toxicity and if untreated measurable disease is present.
• Radiographically measurable disease by mRECIST in at least one site not previously treated by local therapies.
• Must not be receiving treatment with other investigational agents and must not have received any other investigational agent's ≤ 4 weeks prior to registration.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Required lab and acceptable range criteria.
• Women of child-bearing potential and men must agree to use 2 methods of adequate contraception.
• No contraindications to TACE therapy
• Child-Pugh Score A-B
• Ability to understand and the willingness to sign a written informed consent, and the willingness to comply with the requirements of the protocol.
• Life expectancy greater than 3 months.
• Adequate baseline organ and marrow function

You may not qualify if…

• History of hepatitis B
• Women must not be pregnant or breastfeeding
• Presence of other malignancies
• Active or history of Tuberculosis
• Patients with known HIV positive status
• Conditions with impaired immunity or on immunosuppressive medications such as oral steroids, calcineurin inhibitors, or anti-proliferative agents.
• Must have no evidence of significant, uncontrolled concomitant diseases
• Must have no ongoing or active, uncontrolled infections

Where it is running

• The University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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