Trials / Completed
CompletedNCT01648023
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Robert C. Martin · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo | |
| DRUG | Gem-Cis or Gem-Carbo |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2019-01-01
- Completion
- 2019-09-01
- First posted
- 2012-07-24
- Last updated
- 2025-02-27
- Results posted
- 2022-01-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01648023. Inclusion in this directory is not an endorsement.