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Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Primary Hepatocellular Carcinoma

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Trial Information

Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma

Inclusion Criteria:

1. Subjects aged 18 years and above, both genders.

2. Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)

3. No fibrolamellar subtype HCC

4. Not eligible for any other systemic anti-neoplastic treatment approved for HCC

5. Not eligible for Transarterial chemoembolization (TACE ).

6. No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA)
that were used for HCC, are permitted.

7. Not a candidate for curative surgical resection or liver transplantation

8. Measurable disease defined by the identification at least 1 measurable lesion by
MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging
post-procedure to be considered measurable disease.

9. Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)

10. Child's Pugh classification A

11. ECOG performance status 0-1

Exclusion Criteria:

1. Patients progressing to liver failure.

2. No core biopsy within the past 7 days

3. Patients who are eligible for Transarterial Chemoembolization (TACE)

4. Patients on concurrent anti-neoplastic therapy (including interferon)

5. Patients who have received any systemic anti-neoplastic therapy not approved for the
treatment of HCC.

6. Patients on concurrent steroids, other than those allowed for routine antiemetics, or
inhaled steroids

7. Presence of metastasis.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Yaron Ilan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Center


Israel: Ministry of Health

Study ID:




Start Date:

October 2009

Completion Date:

June 2011

Related Keywords:

  • Primary Hepatocellular Carcinoma
  • Primary Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular