Trial · NCT02195011
Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases
NCT02195011, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2018-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases. Trials, record NCT02195011. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02195011
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases
- NCT number
- NCT02195011
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Colorectal Neoplasms
- Interventions
- SIR-Spheres, Regorafenib
- First posted
- 2014-07-21
- Last updated
- 2023-12-05
- Results first posted
- 2018-07-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety | up to 15 months | A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03. |
| Secondary | Number of Patients With an Objective Response (CR or PR) | At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months | Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST v 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease in of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters. |
| Secondary | Median Progression-Free Survival | At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months. | Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions. |
| Secondary | Median Overall Survival | up to 18 months | Defined as the time (in months) from date of randomization to date of death from any cause, or censored at the date last known alive. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety | up to 15 months | All patients who receive at least one dose of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With an Objective Response (CR or PR) | At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months | Includes all patients who have received study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression-Free Survival | At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months. | Includes all patients who received treatment. | months | MEDIAN |
| SECONDARY | Median Overall Survival | up to 18 months | Includes all patients who received treatment. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 25 | Participants | ||
| The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety | Cohort 2: SIR-Spheres/Regorafenib | 1 | Participants | ||
| Number of Patients With an Objective Response (CR or PR) | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 1 | Participants | ||
| Number of Patients With an Objective Response (CR or PR) | Cohort 2: SIR-Spheres/Regorafenib | 0 | Participants | ||
| Median Progression-Free Survival | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 3.7 | 95% Confidence Interval 2.6 to 9.7 | months | |
| Median Progression-Free Survival | Cohort 2: SIR-Spheres/Regorafenib | NA | 95% Confidence Interval NA to NA | months | |
| Median Overall Survival | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 12.1 | 95% Confidence Interval 6.0 to 16.4 | Months | |
| Median Overall Survival | Cohort 2: SIR-Spheres/Regorafenib | NA | 95% Confidence Interval NA to NA | 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 | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 25 | |
| Overall Study | STARTED | Cohort 2: SIR-Spheres/Regorafenib | 1 | |
| Overall Study | COMPLETED | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 0 | |
| Overall Study | COMPLETED | Cohort 2: SIR-Spheres/Regorafenib | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 25 | |
| Overall Study | NOT COMPLETED | Cohort 2: SIR-Spheres/Regorafenib | 1 |
Source ClinicalTrials.gov
Adverse events344
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 | ANAEMIA | Blood and lymphatic system disorders | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 6 | 25 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2: SIR-Spheres/Regorafenib | 0 | 1 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 2 | 25 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Cohort 2: SIR-Spheres/Regorafenib | 0 | 1 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 4 | 25 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Cohort 2: SIR-Spheres/Regorafenib | 0 | 1 | |
| other | MYOCARDIAL INFARCTION | Cardiac disorders | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 1 | 25 | |
| other | MYOCARDIAL INFARCTION | Cardiac disorders | Cohort 2: SIR-Spheres/Regorafenib | 0 | 1 | |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 1 | 25 | |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Cohort 2: SIR-Spheres/Regorafenib | 0 | 1 |
1 to 10 of 344Source ClinicalTrials.gov
See all 344 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 16 | 25 |
| Total, all-cause mortality | Cohort 2: SIR-Spheres/Regorafenib | 0 | 1 |
| Total, other adverse events | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 25 | 25 |
| Total, other adverse events | Cohort 2: SIR-Spheres/Regorafenib | 1 | 1 |
| Total, serious adverse events | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | 10 | 25 |
| Total, serious adverse events | Cohort 2: SIR-Spheres/Regorafenib | 0 | 1 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: Regorafenib/SIR-Spheres/Regorafenib vs Cohort 2: SIR-Spheres/Regorafenib: deaths from any cause | Trial comparisons |
| Cohort 1: Regorafenib/SIR-Spheres/Regorafenib vs Cohort 2: SIR-Spheres/Regorafenib: Number of Patients With an Objective Response (CR or PR) | Trial comparisons |
| Cohort 1: Regorafenib/SIR-Spheres/Regorafenib vs Cohort 2: SIR-Spheres/Regorafenib: The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety | Trial comparisons |
| Cohort 1: Regorafenib/SIR-Spheres/Regorafenib vs Cohort 2: SIR-Spheres/Regorafenib: 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/NCT02195011
GET https://conductscience.org/api/trials/v1/NCT02195011/events?page=2