Study of IMC-1121B (Ramucirumab) in Participants With Liver Cancer Who Have Not Previously Been Treated With Chemotherapy
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Intervention: Ramucirumab (IMC-1121B)
Intervention description: Participants will receive ramucirumab (IMC-1121B) at 8 milligrams per kilogram (mg/kg) administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
Intervention MeSH terms: Ramucirumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver disease; Neoplasms; Liver neoplasms; Carcinoma, Hepatocellular

Summary:

      A study to determine how long ramucirumab (IMC-1121B) will stop cancer from growing in
      participants with liver cancer that cannot be treated with surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant must have histologically-confirmed, unresectable HCC

          -  The participant has at least one unidimensionally-measurable target lesion [≥ 2
             centimeters (cm) with conventional techniques, or ≥ 1 cm by spiral computed tomography
             (CT) or magnetic resonance imaging (MRI)], as defined by Response Evaluation Criteria
             in Solid Tumors (RECIST). Target lesion(s) must not lay within a previously
             irradiated, ablated, or chemoembolized area. If a target 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 participant has a Cancer of the Liver Italian Programme (CLIP) score of 0-3

          -  The participant has a Child-Pugh Classification score of A or B (liver dysfunction)

          -  The participant has provided signed informed consent

        Exclusion Criteria:

          -  The participant has received prior systemic chemotherapy, biologic or anti-angiogenic
             therapy, or investigational systemic therapy for HCC

          -  The participant has had bleeding from esophageal or gastric varices during the 3
             months prior to study participation. Note: If the participant has any history of known
             esophageal varices, or evidence of esophageal varices on CT/MRI, the participant must
             undergo endoscopic evaluation prior to study entry (minimally invasive capsule
             esophageal endoscopy is an acceptable initial modality). The participant with
             endoscopically detected esophageal varices is eligible provided he/she meets all other
             entry criteria. The participant with any history or current evidence of esophageal
             varices must receive oral beta-blocker therapy throughout participation while on
             study, he/she may receive optimal endoscopic therapy as determined by the consulting
             gastroenterologist or hepatologist, and must undergo regular endoscopic follow-up
             throughout participation while on study

          -  The participant has acute hepatitis

          -  The participant has central nervous system (CNS) metastases or carcinomatous
             meningitis

          -  The participant has poorly-controlled hypertension [in other words (ie), blood
             pressure in abnormal range despite medical management]