CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 397 enrolled
Drug / intervention
Doxorubicin 20 mg/m2 +2 moredrug
Likely dose
Doxorubicin 20 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01655693
NCT01655693Phase 3Completed

Multicentre, Randomised, Controlled, Open-label Study Comparing the Efficacy and Safety of Doxorubicin Transdrug™ to Best Standard of Care in Patients With Advanced Hepatocellular Carcinoma. ReLive Study.

Valerio Therapeutics·interventional·Posted Aug 2, 2012·Updated Jun 2, 2021

In Brief

A Phase 3 clinical trial evaluating Doxorubicin 20 mg/m2, Doxorubicin 30 mg/m2, and 1 other intervention for Carcinoma, Hepatocellular. Completed, enrolled 397 participants across 70 sites in 11 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Egypt, France, Germany, Hungary, Italy, Lebanon, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2, 2012
Enrollment StartJun 1, 2012
Primary CompletionMay 1, 2017
Study CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.9 years ago

Interventions

Doxorubicin 20 mg/m2drug

Doxorubicin 30 mg/m2drug

Best Standard of Caredrug