EUCTR2011-002843-92-ES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 TransdrugTM (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
BioAlliance Pharma0 个研究点目标入组 390 人开始时间: 2013年5月16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
- 390
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 higher or equal to 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 larger or equal to 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 higher or equal to 50,000 /mm3
- •- Neutrophil count higher or equal to 1000 /mm3
- •- Hemoglobin higher or equal to 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 97
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 118
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. Prior history of malignancy with the exception of adequately treated basal cell carcinoma or in situ cervical cancer in complete remission since five years at least;
- •6. HCC developed on transplanted liver;
- •7. 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 III or IV NYHA classification), 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 specially 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 method (if applicable);
- •19. Patients unwilling or unable to comply with protocol requirements and scheduled visits.
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