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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Hepatocellular

Thank you

Trial Information

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


Doxorubicin-Transdrug™ (DT) is a nanoparticle formulation of doxorubicin.In in vitro and in
vivo models, DT was shown to overcome the multidrug resistance (MDR) and to be more
effective than doxorubicin on both sensitive and resistant tumour models and in particular
in the X/myc bi-transgenic MDR murine model of HCC.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival(OS) in each group

Outcome Description:

Survival status will be collected at each visit (at least every 2 weeks) during the study treatment period and then every 3 months until death for an expected average of 1 year.

Outcome Time Frame:

at 1 year (expected average)

Safety Issue:

No

Principal Investigator

Philippe Merle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Croix-Rousse Hospital - Lyon-France

Authority:

France: Committee for the Protection of Personnes

Study ID:

BA2011/03/04

NCT ID:

NCT01655693

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Carcinoma, Hepatocellular
  • Intermediate/advanced hepatocellular carcinoma
  • After failure or intolerance to Sorafenib.
  • Carcinoma
  • Stress, Psychological
  • Carcinoma, Hepatocellular

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