Trial · NCT01648023
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
NCT01648023, Phase 2, Completed, Robert C. Martin; results first posted 2022-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin. Trials, record NCT01648023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01648023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
- NCT number
- NCT01648023
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Robert C. Martin
- Conditions
- Unresectable Intrahepatic Cholangiocarcinoma
- Interventions
- LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo, Gem-Cis or Gem-Carbo
- First posted
- 2012-07-24
- Last updated
- 2025-02-27
- Results first posted
- 2022-01-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease) | Assessed at 2, 4 and 6 months. 6 months reported. | 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 reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment. |
| Secondary | Overall Survival | 4.5 Years | Long-term follow-up will occur every 3-4 months for up to one year after discontinuation of active study treatment. Subjects who have completed the long-term follow-up period will be monitored every 3 - 6 months until evidence of progression of disease. Once there is progression of disease subjects will be followed for overall survival by telephone or standard physician follow-ups as per standard of care until death. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease) | Assessed at 2, 4 and 6 months. 6 months reported. | participants | NUMBER | |
| SECONDARY | Overall Survival | 4.5 Years | All randomized subjects who receive at least one cycle of intravenous chemotherapy or LC or ONCOZENE beads loaded with irinotecan. Subjects will be grouped according to their randomization. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease) | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 24 | participants | ||
| Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease) | Randomization to Gem-Cis or Gem-Carbo | 22 | participants | ||
| Overall Survival | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 33.7 | Full Range 13.5 to 54.5 | Months | |
| Overall Survival | Randomization to Gem-Cis or Gem-Carbo | 12.6 | Full Range 8.7 to 33.4 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 25 | |
| Overall Study | STARTED | Randomization to Gem-Cis or Gem-Carbo | 24 | |
| Overall Study | COMPLETED | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 24 | |
| Overall Study | COMPLETED | Randomization to Gem-Cis or Gem-Carbo | 22 | |
| Overall Study | NOT COMPLETED | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 1 | |
| Overall Study | NOT COMPLETED | Randomization to Gem-Cis or Gem-Carbo | 2 |
Source ClinicalTrials.gov
Adverse events302
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Distension | Gastrointestinal disorders | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 3 | 24 | |
| other | Abdominal Distension | Gastrointestinal disorders | Randomization to Gem-Cis or Gem-Carbo | 2 | 22 | |
| other | Abdominal Pain | Gastrointestinal disorders | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 21 | 24 | |
| other | Abdominal Pain | Gastrointestinal disorders | Randomization to Gem-Cis or Gem-Carbo | 5 | 22 | |
| other | Gout | Immune system disorders | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 0 | 24 | |
| other | Gout | Immune system disorders | Randomization to Gem-Cis or Gem-Carbo | 1 | 22 | |
| other | Agitation | General disorders | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 1 | 24 | |
| other | Agitation | General disorders | Randomization to Gem-Cis or Gem-Carbo | 1 | 22 | |
| other | Aguesia | General disorders | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 3 | 24 | |
| other | Aguesia | General disorders | Randomization to Gem-Cis or Gem-Carbo | 0 | 22 |
1 to 10 of 302Source ClinicalTrials.gov
See all 302 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 17 | 24 |
| Total, all-cause mortality | Randomization to Gem-Cis or Gem-Carbo | 16 | 22 |
| Total, other adverse events | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 24 | 24 |
| Total, other adverse events | Randomization to Gem-Cis or Gem-Carbo | 19 | 22 |
| Total, serious adverse events | Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo | 21 | 24 |
| Total, serious adverse events | Randomization to Gem-Cis or Gem-Carbo | 19 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo vs Randomization to Gem-Cis or Gem-Carbo: Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease) | Trial comparisons |
| Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo vs Randomization to Gem-Cis or Gem-Carbo: deaths from any cause | Trial comparisons |
| Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo vs Randomization to Gem-Cis or Gem-Carbo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01648023
GET https://conductscience.org/api/trials/v1/NCT01648023/events?page=2