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Y-90, Capecitabine, and Atezolizumab for Metastatic Colorectal Cancer in the Liver

This study is looking at a combination of three treatments for colorectal cancer that has spread to the liver and cannot be removed by surgery. The treatments are yttrium-90 radioembolization (a type of radiation therapy delivered directly to the liver), capecitabine (a chemotherapy drug), and atezolizumab (an immunotherapy drug). This study is for people who have already received two or more other treatments for their cancer. The main goal is to see how well this combination controls the cancer in the liver after 12 weeks. We are looking for about 18 participants. The current recruitment status is unclear.

Study design
This is a Phase 2 study, meaning it's testing if the treatment works and is safe. It is a single-arm study, so all 18 participants will receive the same combination treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the disease control rate at 12 weeks.

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NCT06555133

Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC

Recruiting
PHASE2Ages 18+InterventionalTreatment
Brown University
~18 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:yttrium-90 radioembolization

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're 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
Measured over 12 weeks

Conditions

Colorectal Carcinoma Metastatic in the Liver

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Rhode Island1

Who to contact

Brown University Oncology Research Group (BrUOG)
[email protected]
401-863-3000
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Eligibility criteria

Exclusion

Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study. 14. Positive for HIV at screening or any time prior to screening: patients without prior positive HIV test result will undergo an HIV test at screening, unless not permitted under local regulations 15. Active Hepatitis B virus (HBV) infection (chronic or acute): defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible for the study 16. Active hepatitis C virus (HCV) infection: defined as positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test 17. Active TB (Mycobacterium tuberculosis) 18. Administration of a live, attenuated vaccine within 28 days before first atezolizumab dose or anticipation that such a live, attenuated vaccine will be required during the study or within 5 months after the final dose of atezolizumab 19. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation 20. Inability to swallow medication 21. History of other malignancy that could affect compliance with the protocol or interpretation of results; patients with a curatively treated skin cancer, in situ cervical cancer, or non-CRC malignancy are eligible if the non-CRC malignancy is controlled and will not interfere with measurement of treatment efficacy or safety 22. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 28 days before the first dose of atezolizumab. 23. Any major surgery or significant traumatic injury within 28 days of initiating study treatment or anticipation of need for a major surgical procedure during the study 24. Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol 25. Pregnancy, breast-feeding, or prisoner status 26. History of leptomeningeal disease 27. Uncontrolled tumor-related pain 28. Patients requiring pain medication must be on a stable regimen at study entry. 29. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.

What this trial measures

  • To assess the preliminary efficacy with the combination of yttrium-90, capecitabine, and atezolizumab based on the intrahepatic disease control rate (iDCR) at 12 weeks12 weeks

    Disease control rate is defined as the proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) within the liver at first post-Y-90 follow-up imaging by NCI's response evaluation criteria in solid tumors (RECIST 1.1), which is a standard way to measure if the tumor is responding to treatment by measuring tumor lesions (cm).