Trial · NCT02162914
Regorafenib Versus Placebo to Treat Cholangiocarcinoma
NCT02162914, Phase 2, Unknown, Erasme University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib Versus Placebo to Treat Cholangiocarcinoma. Trials, record NCT02162914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02162914
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib Versus Placebo to Treat Cholangiocarcinoma
- NCT number
- NCT02162914
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Erasme University Hospital
- Conditions
- Cholangiocarcinoma
- Interventions
- Regorafenib/active, Regorafenib/placebo
- First posted
- 2014-06-13
- Last updated
- 2020-07-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improve median PFS | 6 to 12 weeks | The primary endpoint is to improve median PFS from 6 weeks to 12 weeks in Regorafenib group. |
| Secondary | Evaluation of response rate | At pretreatment visit (14 to 1 days before treatment initiation), every 6 weeks for 3 times then every 8 weeks until progression | -Evaluation of tumor response will be done based on radiological RECIST criteria version 1.1 evaluation (thoraco-abdominal CT scan); |
| Secondary | Correlation between radiological response and metabolic response | At pretreatment visit (14 to 1 days before treatment initiation) | Correlation between radiological response (using RECIST criteria version 1.1) and metabolic response using PET imaging (SUV max modifications). This will only be done if SUV max of the tumor inside the liver at pre-treatment visit is ≥ 175% of the SUV max of the normal liver. |
| Secondary | Correlation between radiologic response rate and "Dynamic tumor response rate" | At day 1 (pre-treatment) and day 15 of cycle 1 | Correlation between radiologic response rate (RECIST criteria version 1.1) and "Dynamic tumor response rate". Dynamic response rate is defined by a 20% modification of tumoral perfusion status determined by quantitative DCE-MRI after 14 days of treatment (D1 compared to D15 values); |
| Secondary | Correlation between dynamic tumor response rate and metabolic response rate | At cycle 1 day 15 | Correlation between dynamic tumor response rate and metabolic response rate (Pet CT) when first Pet CT is positive |
| Secondary | Evaluation of Overall Survival (OS) | After 1 year (March 2015) | Evaluation of OS at one year. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32464280 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02162914
GET https://conductscience.org/api/trials/v1/NCT02162914/registered