EUCTR2010-023602-12-IT进行中（未招募）不适用
A FEASIBILITY STUDY EVALUATING THE EFFICACY AND SAFETY OF SORAFENIB IN PATIENTS WITH ADVANCED HEPATOCELLULAR (HCC) CARCINOMA AND HIV INFECTION TREATED WITH HAART REGIMENS - sorafenib-HAART
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
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.HIV infection serologically proven
- •2.HCC cytologically/histologically proven or diagnosed according to AASLD guidelines for whom invasive treatment modalities (resection, loco-regional therapies) are not indicated (57).
- •3.Child–Pugh score A and B7
- •4.Age = 18 years
- •5.ECOG Performance Status = 2
- •6.Life expectancy of at least 12 weeks
- •7.Presence at least of one measurable lesion according to mRECIST criteria (95). Lesions must be measured by CT-scan or MRI.
- •8.CD4 counts > 100 cells/µL and HIV viral load < 50 copies/mL
- •9.Adequate bone marrow, liver and renal function as assessed by the following laboratory measurements, to be conducted within 7 days prior to screening:
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •1.History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
- •2.Active clinically serious infections (> grade 2 NCI-CTC version 4.0)
- •3.Active AIDS-defining infections within the last 6 months or other active AIDS-defining diseases (according to CDC Classification system for HIV infection) including patients with Kaposi sarcoma
- •4.Patients with CD4 counts < 100 cells/ µL and/or HIV infection that has full drug resistance to any class
- •5.NNRTI-based HAART or Atazanavir or Tipranavir PI-based HAART
- •6.Hepatic encephalopathy = CTC G2
- •7.Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
- •8.Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •9.History of organ allograft or autologous transplant
- •10.Patients with evidence or history of bleeding diathesis
- •11.Patients with clinically significant GI bleeding within 30 days prior to study entry
- •12.Renal failure requiring dialysis
- •13.Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
研究者
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