EUCTR2010-019318-26-NO进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib - REACH
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ImClone LLC
- 入组人数
- 565
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.
- •2. The patient is at least 18 years of age or of an acceptable age according to local regulations, whichever is older.
- •3. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- •4. The patient has a Child-Pugh score of < 9 (Child-Pugh A or B [B7 or B8]).
- •5. The patient has a Barcelona Clinic Liver Cancer (BCLC) stage C at randomization. A patient with BCLC stage B may be eligible if he/she has disease that is not amenable to locoregional therapy or is refractory to locoregional therapy.
- •6. The patient has a diagnosis of HCC (excluding fibrolamellar carcinoma) based on histopathologic or cytologic findings; or in the absence of histologic confirmation, each of the following is present (at the time of study entry):
- •a. There are either clinical, laboratory, or radiographic findings consistent with a diagnosis of liver cirrhosis.
- •b. The patient has a liver mass measuring at least 2 cm with characteristic vascularization seen on either triphasic computed tomography (CT) scan or magnetic resonance imaging (MRI) with gadolinium.
- •7. The patient has at least 1 measurable or evaluable lesion that is viable (ie, is vascularized), and has not been previously treated with locoregional therapy. A lesion that has been previously treated will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy.
- •8. The patient has previously been treated with sorafenib and has discontinued sorafenib treatment at least 14 days prior to randomization. This will include patients who have experienced:
- •a. Radiographically documented disease progression during sorafenib therapy or after discontinuation of sorafenib therapy, or
- •b. Discontinuation of sorafenib due to an adverse drug reaction, despite dose reduction by 1 to 2 levels and BSC.
- •9. The patient has received sorafenib as the most recent systemic therapeutic intervention. Any hepatic locoregional therapy that has been administered prior to sorafenib is allowed, but not following sorafenib. Radiation to metastatic sites (eg, bone) following sorafenib therapy is permitted.
- •10. The patient has resolution to Grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.02 (NCI-CTCAE v 4.02) of all clinically significant toxic effects of prior locoregional therapy, surgery, chemoembolization, or other anticancer therapy, including sorafenib.
- •11. The patient has adequate organ function defined as:
- •a. Total bilirubin < 3.0 mg/dL (51.3 µmol/L), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5 × the institutional upper limit of normal (ULN);
- •b. Serum creatinine = 1.2 × ULN or calculated creatinine clearance > 50 mL/minute;
- •c. Absolute neutrophil count (ANC) = 1.0 × 10exp3/µL (1.0 × 10exp9/L), hemoglobin = 9 g/dL (5.58 mmol/L; packed red blood cell transfusions are not permitted within one week prior to baseline hematology profile), and platelets = 75 × 10exp3/µL (75 × 10exp9/L);
- •d. International Normalized Ratio (INR) = 1.5 and partial thromboplastin time (PTT) = 5 seconds above ULN. Patients receiving prophylactic low-dose anticoagulant therapy are eligible provided that INR = 1.5.
- •12. The patient’s urinary protein is = 1+ on dipstick or routine urinalysis.
- •13. The patient, if female, is surgically sterile, postmenopausal, or com
排除标准
- •1. Patient has undergone major surgery within 28 days prior to randomization, or has undergone central venous access device placement within 7 days prior to randomization.
- •2. Patient has undergone hepatic locoregional therapy (including radiation, surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 28 days prior to randomization.
- •3. Patient has undergone radiation to any nonhepatic site within 14 days prior to randomization.
- •4. Patient has received sorafenib within 14 days prior to randomization.
- •5. Patient has received any investigational therapy within 28 days prior to randomization.
- •6. Patient has received any previous systemic therapy with VEGF inhibitors or VEGFR inhibitors (including investigational agents) other than sorafenib for treatment of HCC.
- •7. Patient has fibrolamellar carcinoma.
- •8. Patient has received any transfusion, blood component preparation, erythropoietin, albumin preparation, or G-CSF within 14 days prior to randomization.
- •9. Patient is receiving therapeutic anticoagulation with warfarin, low-molecular-weight heparin, or similar agents. Patients receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR = 1.5) are met.
- •10. Patient is receiving ongoing therapy with NSAIDs or other antiplatelet agents. Aspirin at doses up to 100 mg/day is permitted.
- •11. Patient has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia.
- •12. Patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
- •13. Patient has uncontrolled arterial hypertension = 150 / = 90 mm Hg despite standard medical management.
- •14. Patient has experienced any Grade 3-4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to randomization requiring transfusion, endoscopic or operative intervention (patients with any bleeding episode considered life-threatening during the 3 months prior to randomization are excluded, regardless of transfusion or intervention status).
- •15. Patient has esophageal or gastric varices that require immediate intervention or represent a high bleeding risk in the opinion of the investigator or consulting gastroenterologist or hepatologist. Patients with evidence of portal hypertension (including splenomegaly) or any prior history of variceal bleeding must have had endoscopic evaluation within the 3 months immediately prior to randomization; these are eligible for study participation if endoscopic evaluation does not indicate esophageal or gastric varices that require immediate intervention or represent a high bleeding risk; however, these eligible patients must receive supportive therapy according to institutional standards and clinical guidelines during study participation. Additional endoscopic assessments during study participation should be performed at the discretion of the consulting gastroenterologist or hepatologist, as clinically indicated.
- •16. Patient has CNS metastases or carcinomatous meningitis.
- •17. Patient has a serious illness or medical condition(s), including but not limited to the following:
- •a. Known HIV infection or AIDS-related illness;
- •b. Active or uncontrolled clinically serious infection
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