Multicentre, Randomised, Controlled, Open-label Study Comparing the Efficacy and Safety of Slow Repeated IV Infusions of 2 Doses of Doxorubicin Transdrug™ (DT) (20mg/m2 and 30mg/m2) to Those of Best Supportive Care (BSC) in Patients Suffering From Advanced Hepatocellular Carcinoma (HCC) After Failure or Intolerance to Sorafenib. ReLive Study
Inclusion Criteria:
- Male or non-pregnant, non-breast feeding female;
- Aged ≥ 18 years;
- Patient 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
- HCC diagnosed according to the AASLD criteria:
- Cyto-histology criteria and/or Non-invasive criteria
- Without cirrhosis or with a non decompensated cirrhosis (Child-Pugh score from A5 to
B7 included);
- ECOG Performance Status 0 or 1;
- Laboratory tests as follows:
- 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);
- Signed and dated written informed consent form.
Exclusion Criteria:
- Cirrhosis with a Child-Pugh score B8-C15;
- Untreated chronic hepatitis B;
- Patients eligible for curative treatments (transplantation, surgical resection,
percutaneous treatment);
- Patients eligible for palliative treatments with demonstrated efficacy: TACE,
sorafenib (patients who failed to sorafenib treatment or intolerant to sorafenib can
be included);
- HCC developed on transplanted liver;
- HIV infection;
- Risk of variceal bleeding;
- SaO2 < 95%;
- Presence of a significant acute or chronic respiratory disease, pleural effusion;
- 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…);
- Patients having undergone a 450 mg/m² cumulated dose of doxorubicin;
- Patients currently treated with immunosuppressive agents that cannot be stopped;
- Patients with unstable ongoing medical/surgical problems;
- Patients with a life expectancy of less than 2 months;
- Patients who had participated in another clinical trial in the last 30 days;
- Women of child-bearing age who are unwilling or unable to use an effective
contraception method during the study treatment period and for 2 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 2 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);
- Patients unwilling or unable to comply with protocol requirements and scheduled
visits.