CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
whole liver lobe cTACE doxorubicin +1 moredrug
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/NCT02753881
NCT02753881Phase 1Completed
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Pharmacokinetics of Doxorubicin in Conventional Transarterial Chemoembolization (cTACE) of Primary and Secondary Liver Cancer

Yale University·interventional·Posted Apr 28, 2016·Updated Aug 3, 2020

In Brief

A Phase 1 clinical trial evaluating whole liver lobe cTACE doxorubicin and superselective cTACE doxorubicin for Liver Cancer. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Patients with primary and secondary liver cancer may participate in this study. The purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an injection of small beads to block the tumor-feeding arteries. Doxorubicin is a chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive super-selective CTACE (i.e., delivered in close proximity to the tumor).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 28, 2016
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.2 years ago

Interventions

whole liver lobe cTACE doxorubicindrug

Doxorubicin CTACE administered in a whole liver lobe manner.

superselective cTACE doxorubicindrug

Doxorubicin CTACE administered in a super-selective (close to the tumor) manner.