Randomized Continuation, Dose Escalation Trial of Sorafenib in Patients With Advanced HCC With Radiological Progression on Prior Sorafenib Treatment (Phase II Study)

Istituto Clinico Humanitas2 个研究点分布在 1 个国家目标入组 142 人开始时间: 2007年4月1日最近更新: 2010年9月2日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 142
试验地点: 2

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of the study is to evaluate, after radiological progression, efficacy in patients treated with Sorafenib at a dose of 600 mg bid compared to that in patients treated with best supportive care.

Primary efficacy objective is progression free survival from randomization.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with advanced/inoperable HCC not eligible for radical or loco-regional therapies Male or female patients ≥ 18 years of age Life expectancy of at least 12 weeks at screening Histologically or cytologically documented HCC
•At least one tumor lesion that meets both of the following criteria:
•The lesion is measurable as per RECIST criteria, and
•The lesion has not been subject to previous loco-regional therapy (such as radiation therapy, TACE, TAE, PEI, RFA, or cryoablation) Patients previously treated with loco-regional treatments are eligible provided that previously treated lesions are not selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan ECOG PS of 0, 1, or 2 Cirrhotic status of Child-Pugh class A or B Barcelona-Clinic Liver Cancer (BCLC) stage B or C
•The following laboratory parameters:
•Platelet count ≥ 60 x 109 /L
•Haemoglobin ≥ 8,5 g/dL
•Total bilirubin ≤ 3 mg/dL
•Alanine transaminase (ALT) and Aspartato transaminase (AST) ≤ 5 x upper limit of normal
•Amylase and lipase < 1,5 x the upper limit of normal
•Serum creatinine ≤ 1,5 x the upper limit of normal
•Prothrombin time (PT)-international normalized ratio (INR) < 2,3 or PT < 0,6 seconds above control. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
•Written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

排除标准

•Previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1).
•Any cancer curatively treated > 3 years prior to entry is permitted Renal failure requiring hemo- or peritoneal dialysis
•History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2;
•active coronary artery disease (CAD);
•cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers ordigoxin), or uncontrolled hypertension.
•Myocardial infarction more than 6 months prior to study entry is permitted if there is no evidence of active CAD
•Active clinically serious infections (> Grade 2 [NCI CTCAE] )
•Known history of human immunodeficiency virus (HIV) infection
•Known Central Nervous System tumors including metastatic brain disease
•Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
•History of organ allograft
•Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
•Patients unable to swallow oral medications
•Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
•Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug.
•Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial

研究者

发起方

Istituto Clinico Humanitas

申办方类型

Other

研究点 (2)

Loading locations...

相似试验

已完成

3 期

Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With NarcolespyNarcolepsyCataplexyExcessive Daytime Sleepiness

NCT01067235Bioprojet14

尚未招募

1 期

Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)Pancreatic Adenocarcinoma

NCT06217666Haoming (Carl) Qiu24

Unknown

不适用

Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal CancerLocally Advanced Rectal Cancer

NCT02964468Grupo de Investigación Clínica en Oncología Radioterapia525

已完成

1 期

Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male ParticipantsHealthy Volunteers

NCT03965728Bayer67

已完成

1 期

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Participants, Participants With Generalized Anxiety Disorder (GAD) and Participants With Bipolar Disorder (BPD)Healthy VolunteersGeneralized Anxiety Disorder (GAD)Bipolar Disorder (BPD)

NCT06024239AbbVie72