Trial · NCT06563986
FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer
NCT06563986, Phase 2, Recruiting, UMC Utrecht
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer. Trials, record NCT06563986. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06563986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer
- NCT number
- NCT06563986
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- UMC Utrecht
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Systemic treatment (FTD-TPI and bevacizumab), Radioembolization with 166-Ho microspheres
- First posted
- 2024-08-21
- Last updated
- 2024-08-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hepatic objective response rate (hORR) (PERCIST 1.0) | Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first. | Hepatic objective response rate (hORR) will be assessed by Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) 1.0. |
| Secondary | Hepatic objective response rate (hORR) (RECIST 1.1) | Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first. | Hepatic objective response rate (hORR) will be assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. |
| Secondary | Overall and extra-hepatic ORR (RECIST 1.1) | Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first. | Overall and extra-hepatic ORR will be assessed by RECIST 1.1. |
| Secondary | Overall and extra-hepatic ORR (PERCIST 1.0) | Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first. | Overall and extra-hepatic ORR will be assessed by PERCIST 1.0. |
| Secondary | Serious adverse events (SAE's) | Evaluated every 8 weeks after start treatment during the first half year. The collection period will start from the first day of the first treatment cycle until 180 days thereafter. | The occurrence of any (suspected unexpected) serious adverse event (SAE) that is possibly, probably or definitely related to the combined treatment. |
| Secondary | Grade ≥3 adverse events (CTCAE 5.0) | Evaluated every 8 weeks after start treatment during the first half year. The collection period will start from the first day of the first treatment cycle until 180 days thereafter. | The rate of grade ≥3 adverse events (CTCAE 5.0). |
| Secondary | Occurrence of radioembolization-induced liver disease (REILD) | Evaluated every 8 weeks after start treatment during the first half year. | Radioembolization-induced liver disease (REILD) is defined as a total bilirubin increase to grade ≥3 or higher according to the CTCAE v5.0, in combination with ascites and low albumin, developing at least 2 weeks after radioembolization and up to 4 months after radioembolization, in the absence of tumor progression or biliary obstruction. |
| Secondary | Radioembolization related vascular events | Evaluated every 8 weeks after start treatment during the first half year. | Number of participants with a vascular event (dissection, pseudo-aneurism, thrombus etc.) that is possibly, probably or definitely related to the radioembolization. |
| Secondary | Dose reductions, dose delays of FTD-TPI | Evaluated during the first two cycles (each cycle is 28 days). | The frequency of dose reductions and dose delays of FTD-TPI during the first 2 cycles. |
| Secondary | Radioembolization completion rate | Evaluated immediately after the radioembolization treatment. | Defined as the successful treatment of both hemi-livers (in case of bilateral disease) according to the individualized treatment plan designed at the scout dose. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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.
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 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06563986
GET https://conductscience.org/api/trials/v1/NCT06563986/registered