Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
yttrium-90 radioembolization
Combination productyttrium-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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: yttriuM-90 in combination with capEcitabine and aTezolizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
12 weeksSecondary outcomes
1
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).
Time frame
Approximately 18 months2
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).
Time frame
Approximately 18 months3
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).
Time frame
Approximately 18 monthsSponsors and contacts
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Source ClinicalTrials.gov