Know Cancer

forgot password

A Multicenter, Phase 2 Study Evaluating IMC-A12 in Combination With Sorafenib as First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

Thank you

Trial Information

A Multicenter, Phase 2 Study Evaluating IMC-A12 in Combination With Sorafenib as First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine progression free survival (PFS) in patients with
unresectable hepatocellular carcinoma who have received no prior systemic therapy when
treated with IMC-A12 administered every three weeks in combination with oral sorafenib
administered twice daily.

Inclusion Criteria:

- The patient has histologically or cytologically confirmed, unresectable HCC

- The patient has at least one target lesion measurable according to Response
Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not
lay within a previously irradiated, ablated, or chemoembolized area. If a lesion
does lie in such an area, there must be evidence of growth on successive imaging
studies, including tumor hypervascularity, in order for such a lesion to be
considered a target lesion

- The patient has not received prior systemic therapy for HCC. Patients may have
received prior embolization, chemoembolization, intra-arterial chemotherapy infusion,
ethanol injection, radiofrequency ablation, or cryosurgery

- The patient has fasting serum glucose < 160 mg/dL or below the ULN and/or hemoglobin
A1C < 7%. If baseline nonfasting glucose < 160 mg/dL, fasting glucose measurement is
not required

- The patient has the ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- The patient has brain metastases

- The patient has acute hepatitis

- The patient has poorly controlled diabetes mellitus. Patients with a history of
diabetes mellitus are allowed to participate, provided that their blood glucose is
within normal range and that they are on a stable dietary or therapeutic regimen for
this condition

- The patient has congestive heart failure > class II NYHA, unstable angina pectoris,
new onset of angina pectoris, myocardial infarction within the past 6 months, or
cardiac ventricular arrhythmias requiring antiarrhythmic therapy

- The patient has experienced a hemorrhage or bleeding event ≥ NCI-CTCAE Grade 3 within
4 weeks prior first dose of study therapy

Type of Study:


Study Design:

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

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

Approximately 2 years

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

June 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Liver Neoplasms
  • Antibodies, Monoclonal
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



ImClone Investigational Site New York, New York  10021
ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site New Orleans, Louisiana  70121
ImClone Investigational Site Philadelphia, Pennsylvania  19107
ImClone Investigational Site Tucson, Arizona  85712
ImClone Investigational Site Boston, Massachusetts  02135