Colorectal Carcinoma Metastatic in the LiverPhase 2METEORITENCT06555133
Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC
A Phase 2 study testing yttrium-90 radioembolization in people with Colorectal Carcinoma Metastatic in the Liver, run by Brown University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma Metastatic in the Liver
- What is being tested?
- yttrium-90 radioembolization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of colorectal adenocarcinoma
- Surgically unresectable, liver-isolated or liver-dominant, RECIST measurable, metastatic disease
- Age ≥18 years at the time of signing informed consent
- ECOG performance status 0 or 1
- Progression on 2 or more lines of systemic therapy
- Agreeable to providing tumor tissue and blood for exploratory correlative analyses
Show all 17Show fewer
- Less than 50% of liver volume replaced by metastatic disease (as determined by investigator)
- 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. Patient may be transfused or receive EPO to meet this criterion
- Renal Serum creatinine OR measured or calculated creatinine clearance ≤1.5 X upper limit of normal (ULN) OR (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
- Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 5 X ULN Alkaline Phosphatase ≤ 5 X ULN Albumin ≥2.5 mg/dL
- Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- ≤1.5 X ULN unless subject is receiving anticoagulant therapy. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- Creatinine clearance should be calculated per institutional standard. Exceptions can be made for patients with known Gilbert disease (≤ 3X ULN)
- Female subjects of childbearing potential must be willing to use an adequate method of contraception from the time of the negative pregnancy test until a minimum of 6 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive (injectable or implantable), or intrauterine device in conjunction with a barrier method. Breast feeding subjects must be willing to discontinue at treatment start and for 5 months post-treatment.
- Male subjects of childbearing potential must agree to use an adequate method of contraception with female partners of childbearing potential including abstinence or condoms plus an additional contraceptive method such as hormonal contraceptive (injectable or implantable), or intrauterine device during the study and for up to 3 months after the last dose of study drug.
- Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures
Who cannot join
- Prior yttrium-90 therapy
- Prior external beam radiation therapy to the liver
- Predicted life expectancy of less than 3 months
- Known mismatch repair deficiency (dMMR), microsatellite instability (MSI-H), or high tumor mutational burden (TMB-H) defined as ≥ 10 mutations per megabase
- 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
- Treatment with investigational therapy within the 28 days of initiation of study treatment
Show all 40Show fewer
- Systemic treatment within 14 days or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- Prior treatment with CD137 agonists or anti-PD1, anti-PD-L1, anti-CTLA4 antibodies
- A history of or current evidence of any condition (e.g. known deficiency of the enzyme dihydropyrimidine dehydrogenase [DPD]), therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Known New York Heart Association class 3/4 congestive heart failure, left ventricular ejection fraction <40% (if previously measured), myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable arrhythmia
- Chronic obstructive pulmonary disease (COPD) requiring oral corticosteroids or chronic oxygen
- History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, granulomatosis with polyangiitis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the exception of: hypothyroidism (on stable dose of thyroid replacement therapy), asthma managed with inhaled medications only; type 1 diabetes mellitus on stable insulin regimen, Sjögren syndrome, immune thrombocytopenia or autoimmune hemolytic anemia that does not require systemic therapy; dermatologic condition (including eczema, psoriasis, lichen simplex chronicus, or vitiligo) with skin manifestations with rash covering <10% of body surface area and not requiring treatment other than low-potency topical corticosteroids for >12 months prior to registration
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
- 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.
- 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
- 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
- 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
- Active TB (Mycobacterium tuberculosis)
- 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
- 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
- Inability to swallow medication
- 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
- 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.
- 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
- Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol
- Pregnancy, breast-feeding, or prisoner status
- History of leptomeningeal disease
- Uncontrolled tumor-related pain
- Patients requiring pain medication must be on a stable regimen at study entry.
- 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.
- Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- Patients with indwelling catheters (e.g., PleurX) are allowed.
- Uncontrolled or symptomatic hypercalcemia (ionized calcium 1.5 mmol/L, calcium 12 mg/dL or corrected serum calcium ULN)
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
- History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Prior allogeneic stem cell or solid organ transplantation
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lifespan Cancer Institute: The Miriam and Rhode Island Hospitals Providence, Rhode Island, United States, 02903 Contact:
Providence, Rhode Island, 02903
Roxanne Wood, BA, 401-863-3000, roxanne_wood@brown.edu
Alexander G Raufi, MD
About this study
Official title: A Phase II Pilot Study of yttriuM-90 in Combination With capEcitabine and aTezolizumab for oligomEtastatic cOlorectal Cancer With unResectable lIver MeTastasEs (METEORITE)
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.
- Being tested
- yttrium-90 radioembolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yttrium-90 radioembolizationCombination product
Also called capecitabine and atezolizumab
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.
| Study group | Role | What they receive |
|---|---|---|
| yttriuM-90 in combination with capEcitabine and aTezolizumab | Experimental | Atezolizumab 1,200 mg IV every 3 weeks for 5 doses Capecitabine 825 mg/m2 PO BID for 2 weeks beginning on the date of each Y-90 therapy administration Y-90 radioembolization one or both hemilivers based on distribution of disease Receives: Combination Product: yttrium-90 radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 12 weeks
Secondary outcomes (3)
To evaluate the preliminary safety of the combination of yttrium-90, capecitabine, and atezolizumab
Adverse events will be collected (side effects) per the National Cancer Institute's Common Terminology Criteria for Adverse Events CTCAE v5 (adverse events (side effects) are graded from 1-5).
Measured: Approximately 18 months
To determine the extrahepatic disease control rate (eDCR) with the combination of yttrium-90, capecitabine, and atezolizumab
assessment of extrahepatic disease control rate (eDCR), measurements from up to three of the target lesions identified outside the liver will be utilized to categorize non-liver response according to 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 lesions (cm).
Measured: Approximately 18 months
To estimate the median overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with the combination of yttrium-90, capecitabine, and atezolizumab
CT imaging will be performed beginning on Day 90 (+7 days) or Day 132 (+7 days) depending on if the participant received one or two doses of Y-90, respectively. Subsequently, imaging is to be performed every 90 days (+14 days) until disease progression according to 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 lesions (cm).
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start7 Apr 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Carcinoma Metastatic in the LiverStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical, Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555133
- Sponsor's protocol ID
- BrUOG 430
- Acronym
- METEORITE
- Status last verified
- Aug 2026
- First submitted
- 2 May 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study of yttriuM-90 in Combination With capEcitabine and aTezolizumab for oligomEtastatic cOlorectal Cancer With unResectable lIver MeTastasEs (METEORITE)
- ClinicalTrials.gov ID
- NCT06555133
- Acronym / sponsor ID
- METEORITE / BrUOG 430
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Sirtex Medical, Genentech, Inc.
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| yttriuM-90 in combination with capEcitabine and aTezolizumab | Experimental | Combination Product: yttrium-90 radioembolizationAtezolizumab 1,200 mg IV every 3 weeks for 5 doses Capecitabine 825 mg/m2 PO BID for 2 weeks beginning on the date of each Y-90 therapy administration Y-90 radioembolization one or both hemilivers based on distribution of disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed diagnosis of colorectal adenocarcinoma
- Surgically unresectable, liver-isolated or liver-dominant, RECIST measurable, metastatic disease
- Age ≥18 years at the time of signing informed consent
- ECOG performance status 0 or 1
- Progression on 2 or more lines of systemic therapy
Key exclusion criteria (40 listed)
- Prior yttrium-90 therapy
- Prior external beam radiation therapy to the liver
- Predicted life expectancy of less than 3 months
- Known mismatch repair deficiency (dMMR), microsatellite instability (MSI-H), or high tumor mutational burden (TMB-H) defined as ≥ 10 mutations per megabase
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yttrium-90 radioembolizationAlso: capecitabine and atezolizumabyttrium-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. | Combination product | yttriuM-90 in combination with capEcitabine and aTezolizumab |
Primary outcome
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
Time frame: 12 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).
3 secondary outcomes
To evaluate the preliminary safety of the combination of yttrium-90, capecitabine, and atezolizumab
Time frame: Approximately 18 months
To determine the extrahepatic disease control rate (eDCR) with the combination of yttrium-90, capecitabine, and atezolizumab
Time frame: Approximately 18 months
To estimate the median overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with the combination of yttrium-90, capecitabine, and atezolizumab
Time frame: Approximately 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing yttrium-90 radioembolization in people with Colorectal Carcinoma Metastatic in the Liver, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brown University Oncology Research Group (BrUOG) (401-863-3000, BrUOG@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.