CTIS2022-502116-36-00招募中1 期
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012) - MK-7902-012
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 549
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Has a diagnosis of hepatocellular carcinoma (HCC) confirmed by radiology, histology, or cytology, Has HCC localized to the liver and not amenable to curative treatment, Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention, Participants with Hepatitis B virus (HBV) are eligible, Has adequately controlled blood pressure with or without antihypertensive medications, Has adequate organ function
排除标准
- •Is currently a candidate for liver transplantation, Has had gastric bleeding within the last 6 months, Has ascites that is not controlled with medication, Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure, Has a serious nonhealing wound, ulcer, or bone fracture, Has received locoregional therapy to existing liver lesions
研究者
相似试验
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular CarcinomaEUCTR2019-002345-37-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc950
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular CarcinomaIncurable/Non-metastatic Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002345-37-DEMerck Sharp & Dohme LLC450
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular CarcinomaIncurable/Non-metastatic Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002345-37-NOMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc950
已完成
3 期
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)liver cancerNL-OMON52824Merck Sharp & Dohme (MSD)12
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular CarcinomaIncurable/Non-metastatic Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002345-37-DKMerck Sharp & Dohme LLC450