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

BioAlliance Pharma0 个研究点目标入组 397 人开始时间: 2013年4月15日最近更新: 2021年12月21日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 397

研究概览入排标准研究者记录与标识符相似试验

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 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.

研究者

发起方

BioAlliance Pharma

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