CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 812 target
Drug / intervention
Solvent with specific gravity less than lipiodol +1 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/NCT01259414
NCT01259414Phase 3Completed
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Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma

Sun Yat-sen University·interventional·Posted Dec 14, 2010·Updated Mar 6, 2019

In Brief

A Phase 3 clinical trial evaluating Solvent with specific gravity less than lipiodol and Solvent with specific gravity equivalent to lipiodol for Hepatocellular Carcinoma. Completed, enrolled 812 participants across 1 site.

Detailed Summary

TACE is considered the standard treatment for unresectable HCC and is widely used as a palliative treatment. However there is no consensus of the protocol of TACE.One of the variation is does the stability of the suspension by emulsified the lipiodol and the contrast medium used to dissolve the anticancer agents really effect the survival.Thus the investigators conduct this prospective,randomized controlled study to find out if the different method of preparing chemotheraputic drugs can cause a different survival benefit.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2010
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 15.5 years ago

Interventions

Solvent with specific gravity less than lipiodolother

TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in distilled water and emulsified lipiodol followed embolization with polyvinyl alcohol particles (PVA)

Solvent with specific gravity equivalent to lipiodolother

TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water,then emulsified with lipiodol followed embolization with polyvinyl alcohol particles (PVA)