Trial · NCT06563986
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Progression free survival (PFS) | Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first. | PFS is defined as time from the first day of the first treatment cycle to progression of disease or death, whichever occurs first. Progression of disease is based on tumor response as observed on radiographic imaging according to RECIST 1.1. |
| Secondary | Overall survival (OS) | Evaluated once per year until the end of the study (the end of study is defined as six months after the first day of the first treatment cycle (each cycle is 28 days) of the 36th evaluable participant). | OS is defined as the time from the first day of the first treatment cycle to the date of death. Patients still alive at the analysis cut-off date are censored at the last date known to be alive. OS will be collected for all patients from the Personal Records Database (BRP), yearly during the duration of the study. |
| Other | Dosimetry scout + post treatment 1 and 2 | Evaluated immediately after the radioembolization treatment. | To evaluate biodistribution / dosimetry using CT and quantitative SPECT both for scout dose imaging and post-treatment imaging. Tumor dose and normal liver dose will be calculated for each hemi-liver in the scout procedure and two post treatment scans. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT06563986/registered