EUCTR2014-005068-13-PL进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 279
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 a diagnosis of HCC based on either:
- •a.histopathologic or cytologic findings
- •b.in the absence of histologic confirmation, a diagnosis of cirrhosis and HCC with classical imaging characteristics (that is, at least a 3-phase liver protocol CT or MRI and a lesion that demonstrates arterial hyperenhancement and washes out in the venous phase).
- •[2]The patient received sorafenib treatment for at least 14 days and discontinued sorafenib treatment ?14 days prior to randomization.
- •[3]The patient experienced radiographically confirmed disease progression during or after discontinuation of sorafenib therapy or discontinued sorafenib treatment because of intolerance despite appropriate sorafenib management and supportive care.
- •[4]The patient received sorafenib as the only systemic therapeutic intervention for advanced HCC.
- •[5]The patient has ?1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (Eisenhauer et al. 2009) that has not been previously treated with locoregional therapy.
- •[6]The patient is ?18 years of age or of an age acceptable according to local regulations, whichever is older.
- •[7]The patient has a Child-Pugh score of <7 (Child-Pugh Class A only).
- •[8]The patient has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy.
- •[9]The patient has a baseline AFP ?400 ng/mL, as determined by local laboratory testing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 148
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 131
排除标准
- •[17]The patient has fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- •[18]The patient had a previous or has concurrent malignancy. Patients with carcinoma in situ of any origin and patients with prior malignancies who are in remission and whose likelihood of recurrence is very low, as judged by the investigator, may be eligible for this study in consultation with and approval by the Lilly CRP.
- •[19]The patient has previously documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
- •[20]The patient has a history of or current hepatic encephalopathy (any grade) or clinically meaningful ascites. Clinically meaningful ascites is defined as CTCAE Grade >1 ascites resulting from cirrhosis. Patients who have been on a stable medical regimen (for ?3 months) to manage ascites are eligible if they show no evidence of ascites on clinical exam that would require further intervention.
- •[21]The patient has ongoing or recent (?6 months prior to randomization) hepatorenal syndrome.
- •[22]The patient had a prior liver transplant.
- •[23]The patient received any previous systemic therapy with VEGF inhibitors or VEGF-Receptor inhibitors (including investigational agents) other than sorafenib for treatment of HCC.
- •[24]The patient received any hepatic locoregional therapy (including radiation, surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) following sorafenib or within 28 days prior to randomization. Use of locoregional therapy prior to sorafenib is allowed.
- •[25]The patient received radiation to any nonhepatic (for example, bone) site within 14 days prior to randomization. Prior radiation to >25% total bone marrow is not allowed.
研究者
相似试验
进行中（未招募）
3 期
Study to evaluate the long-term safety and efficacy of the investigational drug LIB003 for the reduction of cholesterol in patients with Heterozygous Familial HypercholesterolemiaCTRI/2022/01/039679IB Therapeutics LLC
进行中（未招募）
1 期
Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients With Cardiovascular Disease.Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol ReductionMedDRA version: 20.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849EUCTR2020-004392-40-DEIB Therapeutics, LLC900
进行中（未招募）
1 期
A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCAAssociated Vasculitis (AAV).Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitisMedDRA version: 21.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 21.1Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disordersEUCTR2016-001121-14-ITCHEMOCENTRYX, INC.331
进行中（未招募）
不适用
Randomized, Double-Blind, Placebo-Controlled, Phase 2Study of Gemcitabine and Cisplatin Plus Enzastaurinversus Gemcitabine and Cisplatin Plus Placebo,Followed by Maintenance Enzastaurin or Placebo inChemonaive Patients with Advanced, Unresectable, orMetastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer - NDEUCTR2006-005306-31-ITELI LILLY120
进行中（未招募）
1 期
Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients With Cardiovascular Disease.Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol ReductionMedDRA version: 20.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849EUCTR2020-004392-40-NOIB Therapeutics, LLC900