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New treatment option for Colorectal Carcinoma Metastatic in the Liver
Official title Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC
ClinicalTrials.gov ID: NCT06555133
What this study is testing
What is yttrium-90 radioembolization?
yttrium-90 radioembolization is an investigational medicine, being studied as a potential treatment for colorectal carcinoma metastatic in the liver.
Also referred to as capecitabine and atezolizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Known metastasis to the peritoneum or central nervous system. Exceptions include people with untreated brain metastases ≤ 1 cm, if asymptomatic and...
- Treatment with investigational therapy within the 28 days of initiation of study treatment
See the full eligibility criteria
Who can 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
- 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...
- Female people 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...
- Male people 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...
- Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures
What rules you out
- 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 people with untreated brain metastases ≤ 1 cm, if asymptomatic and not requiring immediate radiation or steroids, and people with brain...
- Treatment with investigational therapy within the 28 days of initiation of study treatment
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.