CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 668 target
Drug / intervention
Embolization +2 moreother
Likely dose
Not stated in 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/NCT01229839
NCT01229839Phase 3Completed
CompareCT.gov

Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Mixing the Chemotherapy With Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.

Sun Yat-sen University·interventional·Posted Oct 28, 2010·Updated Mar 6, 2019

In Brief

A Phase 3 clinical trial evaluating Embolization, Infusion of anticancer agent, and 1 other intervention for Hepatocellular Carcinoma. Completed, enrolled 668 participants across 1 site.

Detailed Summary

TACE is considered the standard treatment for unresectable HCC on the basis of the fact that there are no alternative to curative procedures.But the optimal combined regimen is still unclear. One of the controversy is do the protocol should contain lipiodo and how to executer. The investigators hypothesize that TACE without mixing the chemotherapy with lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2010
Enrollment StartAug 1, 2013
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 15.7 years ago

Interventions

Embolizationother

embolization with lipiodol and polyvinyl alcohol particles (PVA)

Infusion of anticancer agentother

infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water

Infusion of mixture of anticancer agent and lipiodolother

infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water