JPRN-jRCT2080222919已完成3 期
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •A diagnosis of HCC based on histopathologic findings, or a diagnosis of cirrhosis and a tumor with classical HCC imaging characteristics.
- •-Prior sorafenib treatment for at least 14 days and discontinuation of sorafenib more than or equal14 days prior to randomization.
- •-Radiographic disease progression during or after sorafenib therapy or discontinuation of sorafenib because of intolerance.
- •-Sorafenib was the only systemic therapy for HCC.
- •-More than or equal1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 that has not been previously treated with locoregional therapy.
- •-Child-Pugh score less than 7 (Child-Pugh Class A).
- •-Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy.
- •-Baseline AFP more than or equal 400 nanograms/milliliter.
- •-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •-Resolution of all clinically significant toxic effects of prior therapy.
- •-Total bilirubin less than or equal 1.5 times upper limit of normal value (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal 5 times ULN.
- •-Creatinine clearance more than or equal 60 milliliters/minute.
- •-Urinary protein is less than or equal 1+ on dipstick or routine urinalysis or 24-hour urine demonstrating less than 1 gram of protein.
- •-Absolute neutrophil count more than or equal 1.0 x 10^9/Liter, hemoglobin more than or equal 9 grams/deciliter, and platelets more than or equal 75 x 10^9/Liter.
- •-International Normalized Ratio (INR) less than or equal 1.5 and a partial thromboplastin time (PTT) less than or equal 5 seconds above the ULN.
- •-Surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method.
- •-If a woman of childbearing potential, a negative serum pregnancy test prior to randomization.
- •-Willing to provide blood for research.
排除标准
- •-Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- •-Concurrent malignancy. Participants with carcinoma in situ of any origin and participants with prior malignancies in remission may be eligible with sponsor approval.
- •-Previous brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
- •-History of or current hepatic encephalopathy or clinically meaningful ascites.
- •-Ongoing or recent hepatorenal syndrome.
- •-Liver transplant.
- •-Previous systemic therapy with vascular endothelial growth factor (VEGF) pathway inhibitors other than sorafenib for treatment of HCC.
- •-Hepatic locoregional therapy following sorafenib or within 28 days prior to randomization.
- •-Major surgical procedure, traumatic injury, non-healing wound, or peptic ulcer less than or equal 28 days prior to randomization.
- •-Placement of a subcutaneous venous access device within 7 days prior to the first dose of study treatment unless the procedure is judged of low risk of bleeding.
- •-Enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or in medical research judged not to be scientifically or medically compatible with this study.
- •-Discontinued from study treatment from another clinical trial within 28 days prior to randomization.
- •-Known allergy to any of the treatment components.
- •-Uncontrolled hypertension.
- •-Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, less than 6 months prior to randomization.
- •-Any bleeding episode considered life-threatening, or any Grade 3 or 4 gastrointestinal bleeding episode in the 3 months prior to randomization requiring intervention.
- •-Esophageal or gastric varices that require intervention or represent high bleeding risk. Participants with evidence of portal hypertension or prior bleeding must have had endoscopic evaluation within 3 months prior to randomization.
- •-Gastrointestinal perforation or fistulae within 6 months prior to randomization.
- •-Symptomatic congestive heart failure (New York Heart Association II-IV), unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia.
- •-Pregnant or breast-feeding.
- •-Any medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. Conditions include but are not limited to:
- •a. Human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
- •b. Active or uncontrolled clinically serious infection. (Participants with chronic viral hepatitis are eligible.)
- •c. Ongoing or recent history of drug abuse.
- •d. Uncontrolled hereditary or acquired thrombotic or bleeding disorder.
- •-Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
- •-Therapeutic dose anticoagulation with warfarin, low molecular-weight heparin, or similar agents.
- •-Chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin at doses up to 100 milligrams/day is permitted.
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