Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether yttrium-90 radioembolization, which delivers radiation directly to liver tumours through their blood supply, can be combined with capecitabine and atezolizumab, an immunotherapy drug, to control unresectable colorectal cancer that has spread to the liver after at least two previous treatment lines.
The idea is that treating the liver deposits locally while continuing drug treatment could keep the cancer in the liver under control. The trial measures the proportion of participants whose intrahepatic disease is controlled at 12 weeks, rather than whether they live longer.
Worth knowing: This is a small, single-arm phase 2 trial with no comparison group, so it cannot show whether the combination is better than other available treatments.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06555133 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 18 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Brown University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Combination product yttrium-90 radioembolization
What it is measuring
To assess the preliminary efficacy with the combination of yttrium-90, capecitabine, and atezolizumab based on the intrahepatic disease control rate (iDCR) at 12 weeks
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
BrUOG-430 is a prospective, single-arm, phase 2 trial evaluating yttrium-90 radioembolization in combination with capecitabine and atezolizumab for the treatment of unresectable colorectal cancer liver metastases in individuals who have been treated with two or more lines of systemic therapy.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Histologically confirmed diagnosis of colorectal adenocarcinoma
2. Surgically unresectable, liver-isolated or liver-dominant, RECIST measurable, metastatic disease
3. Age ≥18 years at the time of signing informed consent
4. ECOG performance status 0 or 1
5. Progression on 2 or more lines of systemic therapy
6. Agreeable to providing tumor tissue and blood for exploratory correlative analyses
7. Less than 50% of liver volume replaced by metastatic disease (as determined by investigator)
8. Demonstrate adequate organ function as defined in table below (all screening labs should be performed within 14 days of atezolizumab initiation):
Hematologic Absolute neutrophil count (ANC) ≥1,500 /mcL or ≥1,200 /mcL for those with benign ethnic neutropenia Absolute Lymphocyte Count (ALC) ≥ 0.5 x 109/L (500/uL) Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L within 7 days of assessment.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06555133, registered by Brown University on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.