A Study of Ramucirumab (LY3009806) in Participants With Advanced Liver Cancer

This is an interventional treatment trial for Carcinoma, Hepatocellular Read More

Inclusion Criteria:

• Histological or cytological diagnosis of hepatocellular carcinoma (HCC) or imaging findings consistent with HCC in a participant with liver cirrhosis and alpha-fetoprotein > 200 nanogram per milliliter
• At least 1 measurable or non-measurable lesion
• Child-Pugh A
• Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Have not received previous systemic therapy for advanced HCC
• Have resolution to Grade ≤1 of all clinically significant toxic effects of prior locoregional therapy
• Adequate organ function including: Absolute neutrophil coun t≥1.5×109/liter (L), hemoglobin ≥9 gram/deciliter, and platelets ≥90×109/L; Total bilirubin level ≤1.5 the upper limit of the normal range (ULN), aspartate transaminase and alanine transaminase ≤5 ULN, albumin >28 gram/L; Serum creatinine level ≤1.5 ULN; or calculated serum creatinine clearance ≥50 milliliter/minute; International Normalized Ratio≤1.5 and partial thromboplastin time ≤5 seconds above ULN
• The urinary protein is ≤ 1+. If ≥ 2+ proteinuria, the 24-hour urine protein is <1000 milligram
• An estimated life expectancy of at least 12 weeks

Exclusion Criteria:

• Received any investigational therapy or non-approved drug within 28 days prior to enrollment
• Undergone major surgery within 28 days prior to enrollment, or undergone central venous access device placement within 7 days prior to enrollment
• Undergone hepatic locoregional therapy within 28 days prior to enrollment
• Undergone radiation to any nonhepatic site within 14 days prior to enrollment
• Prior liver transplant
• Fibrolamellar carcinoma or cholangiocellular carcinoma
• Received any transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte-colony stimulating factors within 14 days prior to enrollment
• Receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents
• Receiving ongoing therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents.
• Known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
• Active or uncontrolled clinically serious infection
• Uncontrolled thrombotic or hemorrhagic disorder
• Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
• History of gastrointestinal perforation or obstruction
• History of or current hepatic encephalopathy or current clinically meaningful ascites
• Known allergy to monoclonal antibody, fluorouracil, oxaliplatin or their excipients
• Interstitial pneumonia or interstitial fibrosis of the lung
• Central nervous system metastases or carcinomatous meningitis
• Known history of dihydropyrimidine dehydrogenase deficiency
• Symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
• Experienced any arterial thromboembolic event
• Uncontrolled arterial hypertension
• Grade 3-4 venous thromboembolic events occurring within 3 months prior to enrollment
• Experienced any grade 3-4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion, endoscopic or operative intervention
• Esophageal or gastric varices that require immediate intervention or represent a high bleeding risk
• Pre-existing grade ≥ 2 motor or sensory neuropathy