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

• Status: Withdrawn
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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