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

NCT02997956 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: UMCC 2015.105HUM00104809
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose of Tocilizumab

  The MTD is defined as the dose of Tocilizumab that induces dose-limiting toxicity in 20% of subjects or less when added to TACE. Patients must complete 84 days of treatment before the dose can be escalated.

  84 Days Post Treatment

• Median Progression Free Survival

  Patients will be followed every 3 months for 2 years post treatment. Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. Progressive disease is defined as at least a 20% increase in the sum of the LD or the appearance of one or more new lesions.

  2 Years Post Treatment

Secondary Outcomes (2)

• Number of patients that respond to treatment

  2 Years Post Treatment

• Number of patients alive at two years post treatment

  2 Years Post Treatment

Study Arms (1)

Tocilizumab

EXPERIMENTAL

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.

Drug: Tocilizumab; Procedure: Transcatheter Arterial Chemoembolization

Interventions

Tocilizumab DRUG

Participants will receive Tocilizumab (ACTEMRA®) at 4, 6, or 8 mg/kg IV dose escalation on days 1, 29 and 57.

Also known as: ACTEMRA

Tocilizumab

Transcatheter Arterial Chemoembolization PROCEDURE

Minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply

Also known as: TACE

Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Theodore Welling, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: July 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2022
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (1)