Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma

Completed · Phase 3

Conditions studied: Carcinoma, Hepatocellular

In brief

The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC) after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and with good liver functions are eligible. Only those who can not benefit from treatment for which efficacy is demonstrated are eligible. These patients are usually proposed either best standard of care (BSC) or participation to clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2 or DT at 30 mg/m2 or the BSC.

Key facts

Study ID: NCT01655693
Run by: Valerio Therapeutics
People needed: 397
Starts: 2012-06-01
Expected to finish: 2019-05-01
Last updated by the study team: 2021-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Patients with porta hepatis lymph nodes, extrahepatic metastases, or portal/suprahepatic vein thrombosis without extension in inferior/superior vena cava, are eligible;
HCC diagnosed according to the American Association for Study of Liver Diseases (AASLD) and/or European Association for the Study of the Liver (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);
Without cirrhosis or with a non decompensated cirrhosis (Child-Pugh score from A5 to B7 included);
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
Laboratory tests as follows:
Platelets ≥ 50,000 /mm3
Neutrophil count ≥ 1000/mm3
Hemoglobin ≥ 10g/dL
Serum transaminases < 5 upper limit normal (ULN) (NCI/common toxicity criteria (CTC) grades 0, 1, or 2)
Alkaline phosphatases < 5 ULN (NCI/CTC grades 0, 1, or 2)
Serum bilirubin < 35 micromolar (µM)/L (or 2.0 mg/dL);
Signed and dated written informed consent form.

You may not qualify if…

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 are eligible and can be included if Sorafenib has been stopped at least 2 weeks before randomization;
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;
HCC developed on transplanted liver;
HIV infection;
Risk of variceal bleeding;
Oxygen saturation (SaO2) < 95%;
Presence of a significant acute or chronic respiratory disease defined as NCI/CTCAE > grade 2;
Presence of recent (< 6 months) or current cardiac failure (class III or IV New York Heart Association (NYHA) classification), recent (< 6 months) acute coronary syndrome, clinically significant ECG abnormalities or recent (less than 6 months) acute vascular diseases (stroke, myocardial infarction (MI)…);
Prior cumulative dose of 300 mg/m² of doxorubicin or equivalent;
Patients currently treated with immunosuppressive agents that cannot be stopped;
Patients whose medical or surgical conditions are unstable and may not allow the study completion or compliance, and specially patients with uncontrolled diabetes;
Uncontrolled systemic infection;
Patients with a life expectancy of less than 2 months;
Patients who have received an experimental drug in another clinical trial in the last 30 days prior to randomization in the present clinical trial;
Women of child-bearing age who are unwilling or unable to use an effective contraception method 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);
Patients unwilling or unable to comply with protocol requirements and scheduled visits.

Where it is running

Penn State Hershey Cancer Institute — Hershey, Pennsylvania, United States
Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
Krankenhaus der Elisabethinen Linz GmbH — Linz, Austria
Medical University Vienna — Vienna, Austria
CHU Brugmann — Brussels, Belgium
UCL Saint-Luc — Brussels, Belgium
CHU Sart Tilman — Liège, Belgium
CHU UCL Mont-Godinne Dinant — Yvoir, Belgium
Medical Oncology department /Mansoura University Hospitals — Al Mansurah, Egypt
Clinical Research Center/ Alexandria university hospital — Alexandria, Egypt
Oncology Department, Medical Research Institute, Alexandria University — Alexandria, Egypt
Medical Oncology department /Ain Shams University Hospitals — Cairo, Egypt
National hepatology and tropical medicine research institute — Cairo, Egypt
National Liver Institute / Menoufyia University — Menofia, Egypt
Hospital Amiens — Amiens, France
Hospital Jean Minjoz — Besançon, France
Hospital Saint André — Bordeaux, France
Centre hospitalier P Oudot — Bourgoin, France
Hospital Estaing — Clermont-Ferrand, France
Centre Hospitalier Beaujon — Clichy, France
Hospital Henri-Mondor — Créteil, France
Centre Jean-François Leclerc — Dijon, France
CHU — Dijon, France
Hospital Grenoble — La Tronche, France
Gabrail Cancer Center — Canton, Ohio, United States

Full record on ClinicalTrials.gov

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