At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
Gem-Cis or Gem-Carbo +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.
Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carboplatin With Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
In Brief
A Phase 2 clinical trial evaluating LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo and Gem-Cis or Gem-Carbo for Unresectable Intrahepatic Cholangiocarcinoma. Completed, enrolled 49 participants across 1 site.
Detailed Summary
The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionJan 2019
Study CompletionSep 2019
TodayJul 2026
First PostedJul 24, 2012
Enrollment StartJul 1, 2012
Primary CompletionJan 1, 2019
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 13.9 years ago
Interventions
LC or ONCOZENE Bead with Gem-Cis or Gem-Carbodevice
Gem-Cis or Gem-Carbodrug