EUCTR2006-004088-77-BE进行中（未招募）1 期
Doxorubicin-Transdrug® in Advanced HepatoCellular CarcinomaA Randomized, Multicenter Phase 2-3 Study. - DOTAHCC1
BioAlliance Pharma0 个研究点目标入组 210 人开始时间: 2007年9月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •18 to 80 years;
- •Patients with hepatocellular carcinoma (HCC), diagnosed according to AASLD guidelines;
- •Multinodular HCC regardless of the number of lesions, but with extension < 50% of the liver parenchyma;
- •Child-Pugh stage A;
- •Left ventricular ejection fraction (LVEF) = 50% as determine by echocardiograph;
- •Adequate pulmonary function as measured by :
- •-a vital capacity (VC) > 70% of the theoretical
- •-a total lung capacity > 70% of the theoretical
- •-a carbon monoxide diffusing capacity (DLCO) > 70% of the theoretical and a DLCO/VA > 70% of the theoretical
- •-a forced expiratory volume in first second (FEV1)/ VC > 60%
- •-a SaO2 > 92% ;
- •Platelets = 75 x 109 L;
- •Absolute neutrophil count = 1,0 x 109 L;
- •AST and/or ALT = 5 times upper limit of normal (NCI/CTC Grade 0, 1, 2);
- •Prothrombin activity > 60% and V factor > 60%;
- •ECOG score 0 - 2 ;
- •Patients who have signed and dated written informed consent;
- •Completed a period of at least 30 days since ending investigational device or drug trial;
- •Women of childbearing potential should have highly effective contraception method (hormonal contraception, implantable contraceptive, injectable contraceptive double-barrier method or intrauterine device) required over 3 months prior and throughout the entire duration of the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Troncular or supra-hepatic vein thrombosis;
- •Right and left lobar portal thrombosis;
- •Risk for variceal bleeding diagnosed on a gastro-duodenal fibroscopy performed at least one year before enrolment and characterized by:
- •-Large esophageal varices or isolated cluster of varices in fundus of stomach
- •-Red wale marks (longitudinal red streaks on varices)
- •-Cherry-red spots (red, discrete, flat spots on varices)
- •-Hematocystic spots (red, discrete, raised spots)
- •-Diffuse erythema;
- •HCC developed on a transplanted liver;
- •Presence of extra-hepatic metastases;
- •Patients able to benefit from a hepatic transplantation, surgical resection, percutaneous ethanol injection or radiofrequency ablation;
- •Prior systemic chemotherapy, TACE, embolisation, radiation therapy for HCC regardless of the time elapsed before the enrolment;
- •Patient having undergone a 450mg/m² cumulated dose of doxorubicin;
- •Patients who has benefited from a surgical resection or percutaneous treatment in the month preceding the enrolment;
- •Patient currently being treated by an immunosuppressor agent that cannot be stopped;
- •Patient treated by an anticoagulant that cannot be stopped;
- •Patient with unstable and developing medical-surgical problems;
- •Presence of cardiac insufficiency, ongoing coronaropathy, arrhythmia or conduction disorders on the electrocardiogram;
- •Patient with a life expectancy of less than 3 months;
- •Pregnant or breast-feeding women;
- •Patients with a mental deficiency preventing proper understanding of trial protocol requirements;
- •Prior entry into this study.
研究者
相似试验
进行中（未招募）
不适用
Doxorubicin-Transdrug® in Advanced HepatoCellular CarcinomaA Randomized, Multicenter Phase 2-3 Study. - DOTAHCC1Advanced hepatocarcinoma (HCC)EUCTR2006-004088-77-DEBioAlliance Pharma210
Unknown
4 期
Safety and Efficacy of Doxorubicin-eluting-bead Embolization in Patients With Advanced Hepatocellular CarcinomaHepatocellular CarcinomaNCT02525380Seoul National University Hospital30
终止
不适用
Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine TumorsGastrointestinal Carcinoid TumorIslet Cell TumorMetastatic CancerNCT00730483Yale University13
进行中（未招募）
1 期
Phase II study evaluating the combination of liposomal doxorubicin pluscyclophosphamide with trastuzumab followed by docetaxel plustrastuzumab as therapy to be performed before surgery (neoadjuvantchemotherapy) for patients with breast cancer more than 2 cm in size and possible involvement of the lymph nodes adjacent and with the receptor HER2 positive.MedDRA version: 14.1Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 100000004864ocal advanced breast cancer resectable, neoadjuvant settingEUCTR2013-002684-25-ITS.I.C.O.G. ONLUS41
已完成
不适用
Deferasirox for patients with advanced hepatocellular carcinoma : pilot studyadvanced hepatocellular carcinomaJPRN-UMIN000013451Yamaguchi University School of Medicine15