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NCT01648023 · ClinicalTrials.gov registry record · Phase 2
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
A Phase 2 study, sponsored by Robert C. Martin.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT01648023: Completed Phase 2 study, sponsored by Robert C. Martin.
NCT01648023 is a Phase 2 study that has completed, run by Robert C. Martin. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01648023, a Phase 2 study, has completed, sponsored by Robert C. Martin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study 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.
Primary Outcome
Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will be classified as: Complete Response - disappearance of all lesions; Partial Response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter or 30% reduction in arterial enhancement; Progressive Disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as referen
Interventions
- DEVICE LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
- DRUG Gem-Cis or Gem-Carbo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-07 |
| Est. Completion | 2019-09 |
| Phase | Phase 2 |
What the finished NCT01648023 record still lists
NCT01648023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo is the first listed.
NCT01648023 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01648023 about?
NCT01648023 is a clinical study titled "Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin". 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.
What is the current status of trial NCT01648023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2012-07. Estimated completion is 2019-09.
What interventions are being tested in trial NCT01648023?
The interventions under investigation include: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo (DEVICE), Gem-Cis or Gem-Carbo (DRUG).
Who is sponsoring clinical trial NCT01648023?
This trial is sponsored by Robert C. Martin, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01648023's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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