RecruitingColorectal Carcinoma Metastatic in the Liver
Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Brown University
You may qualify if…
- ✓ 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):
You may not qualify if…
- ✕ 1. Prior yttrium-90 therapy
- ✕ 2. Prior external beam radiation therapy to the liver
- ✕ 3. Predicted life expectancy of less than 3 months
- ✕ 4. Known mismatch repair deficiency (dMMR), microsatellite instability (MSI-H), or high tumor mutational burden (TMB-H) defined as ≥ 10 mutations per megabase
- ✕ 5. Known metastasis to the peritoneum or central nervous system. Exceptions include subjects with untreated brain metastases ≤ 1 cm, if asymptomatic and not requiring immediate radiation or steroids, and subjects with brain metastases that are treated and stable for 1 month
- ✕ 6. Treatment with investigational therapy within the 28 days of initiation of study treatment
- ✕ 7. Systemic treatment within 14 days or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- ✕ 8. Prior treatment with CD137 agonists or anti-PD1, anti-PD-L1, anti-CTLA4 antibodies
Where it's recruiting
Rhode Island
Providence
Source: ClinicalTrials.gov · NCT06555133 · last updated 2025-04-09