EUCTR2011-002843-92-DE进行中（未招募）1 期
Multicentre, randomised, controlled, open-label, study comparing the efficacy and safety of slow repeated intravenous infusions of 2 doses of Doxorubicin Transdrug™ (DT) (20 mg/m² or 30 mg/m²) to those of best standard of care (BSC) in patients with advanced hepatocellular carcinoma (HCC) after failure or intolerance to sorafenib - ReLive Study - ReLive
Onxeo0 个研究点目标入组 397 人开始时间: 2013年12月2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
- 397
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. Male or non-pregnant, non-breast feeding female;
- •2. Aged = 18 years;
- •3. Patients with
- •- advanced HCC (BCLC-C according to BCLC staging classification) having progressed under Sorafenib therapy or intolerant to Sorafenib, or
- •- intermediate HCC (BCLC-B) non eligible or non responders to transarterial chemoembolization (TACE), and having progressed under or intolerant to Sorafenib therapy;
- •4. Patients with porta hepatis lymph nodes, extrahepatic metastases, or portal/suprahepatic vein thrombosis without extension in inferior/superior vena cava, are eligible;
- •5. HCC diagnosed according to the AASLD and/or EASL criteria:
- •- Radiological Criteria applicable in cirrhotic liver:
- •- Nodule = 10 mm: one imaging technique among MRI and CT-scan showing typical appearances for HCC defined as arterial enhancement and rapid washout in portal venous or delayed phase;
- •- If appearance not typical for HCC on initial imaging: second contrast enhanced study (CT or MRI) showing typical appearances for HCC defined as arterial enhancement and rapid wash-out in portal venous or delayed phase;
- •- And/Or cyto-histology criteria (e.g. in case of atypical lesions for HCC at imaging, absence of cirrhosis);
- •6. Without cirrhosis or with a non decompensated cirrhosis (Child-Pugh score from A5 to B7 included);
- •7. ECOG Performance Status 0 or 1;
- •8. Adequate laboratory tests, in particular with:
- •- Platelets = 50,000 /mm3
- •- Neutrophil count = 1000 /mm3
- •- Hemoglobin = 10g/dL
- •- Serum transaminases < 5 ULN (NCI/CTC grades 0, 1, or 2)
- •- Alkaline phosphatases < 5 ULN (NCI/CTC grades 0, 1, or 2)
- •- Serum bilirubin < 35 µM/L (or 2.0 mg/dL);
- •9. Signed and dated written informed consent form.
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 203
排除标准
- •1. Cirrhosis with a Child-Pugh score B8-C15;
- •2. Untreated chronic hepatitis B (in case of chronic hepatitis B, an efficacious antiviral treatment should have been started before randomisation to be included in the study);
- •3. Patients eligible for curative treatments (transplantation, surgical resection, percutaneous treatment);
- •4. Patients eligible for palliative treatments with demonstrated efficacy: TACE, Sorafenib; Patients who failed to Sorafenib treatment or intolerant to Sorafenib are eligible and can be included if Sorafenib has been stopped at least 2 weeks before randomization;
- •5. Other prior malignancy without complete remission in the last five years with the exception of adequately treated basal cell carcinoma or in situ cervical cancer. In case of other prior malignancy, the diagnosis of HCC has to be histologically proven;
- •6. HCC developed on transplanted liver;
- •7. Known HIV infection;
- •8. Risk of variceal bleeding - i.e. patients with stage 2-3 varices with fragility signs (patients at risk for variceal bleeding may be included after a preventive treatment (oesophageal varices ligation, beta blockers)) has been administered; DT will not be administered in case of digestive bleeding in the 4 previous weeks;
- •9. SaO2 < 95%;
- •10. Presence of a significant acute or chronic respiratory disease defined as NCI /CTCAE > grade 2;
- •11. Presence of recent (< 6 months) or current cardiac failure (class II, III or IV NYHA classification), baseline LVEF < LLN by either cardiac ultrasound or cardiac scintigraphy; recent (< 6 months) acute coronary syndrome, clinically significant ECG abnormalities or recent (less than 6 months) acute vascular diseases (stroke, MI…);
- •12. Prior cumulative dose of 300 mg/m² of doxorubicin or equivalent;
- •13. Patients currently treated with immunosuppressive agents that cannot be stopped;
- •14. Patients whose medical or surgical conditions are unstable and may not allow the study completion or compliance, and especially patients with uncontrolled diabetes;
- •15. Uncontrolled systemic infection;
- •16. Patients with a life expectancy of less than 2 months;
- •17. Patients who have received an experimental drug in another clinical trial in the last 30 days prior to randomization in the present clinical trial;
- •18. Women of child-bearing age who are unwilling or unable to use an effective contraception method (oral contraception or intra-uterine device for woman) during the study treatment period and for 6 months after the last administration of study drug, and their male partner(s) refusing to use a condom (if applicable),
- •Men who are unwilling or unable to use a condom during the study treatment period and for 6 months after the last administration of study drug, and their female partner(s) refusing to use one of the appropriate effective contraception methods (if applicable);
- •19. Patients unwilling or unable to comply with protocol requirements and scheduled visits.
研究者
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