Actively Recruiting
Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC
Led by Brown University · Updated on 2025-04-09
18
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
Sponsors
B
Brown University
Lead Sponsor
S
Sirtex Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma
- Liver-isolated or liver-dominant metastatic disease that is surgically unresectable and measurable by RECIST
- Age 18 years or older at time of consent
- ECOG performance status of 0 or 1
- Disease progression after two or more lines of systemic therapy
- Willingness to provide tumor tissue and blood samples for research
- Less than 50% of liver volume replaced by metastatic disease
- Adequate organ function as defined by specific blood and chemistry lab values within 14 days prior to treatment
- Female participants of childbearing potential agree to use effective contraception from negative pregnancy test until 6 months after last study drug dose
- Male participants of childbearing potential agree to use contraception during study and for 3 months after last study drug dose
- Ability to understand and provide informed consent and comply with study procedures
You will not qualify if you...
- Previous treatment with yttrium-90 radioembolization
- Previous external beam radiation to the liver
- Life expectancy less than 3 months
- Known mismatch repair deficiency, microsatellite instability-high, or high tumor mutational burden
- Metastases to peritoneum or central nervous system, except stable small brain metastases
- Investigational therapy within 28 days before study treatment
- Systemic therapy within 14 days or 5 half-lives before study treatment
- Previous treatment with CD137 agonists or certain immune checkpoint inhibitors
- Conditions or lab abnormalities that interfere with trial participation or safety
- Significant heart conditions or recent heart events
- COPD requiring oral steroids or chronic oxygen
- History of autoimmune diseases except certain stable or mild forms
- Recent systemic immunosuppressive medication use except specific low-dose exceptions
- Positive HIV test or active hepatitis B or C infection
- Active tuberculosis
- Recent live vaccine administration or planned live vaccines during study
- Severe allergic reactions to antibodies or study drug components
- Inability to swallow medication
- Other active malignancies affecting study compliance or results
- Active infections or recent severe infections requiring hospitalization
- Recent major surgery or trauma
- Significant uncontrolled medical or psychiatric conditions
- Pregnancy, breastfeeding, or prisoner status
- History of leptomeningeal disease
- Uncontrolled tumor pain or unstable pain medication regimen
- Symptomatic lesions requiring prior treatment
- Uncontrolled pleural, pericardial effusions, or ascites requiring frequent drainage
- Uncontrolled hypercalcemia
- History or evidence of certain lung diseases or active pneumonitis
- Prior allogeneic stem cell or organ transplantation
- Conditions contraindicating investigational drug use or increasing risk
- Recent treatment with systemic immunostimulatory agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lifespan Cancer Institute: The Miriam and Rhode Island Hospitals Providence, Rhode Island, United States, 02903 Contact:
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
B
Brown University Oncology Research Group (BrUOG)
CONTACT
A
Alexander G Raufi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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