Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC

Conditions

• Colorectal Carcinoma Metastatic in the Liver

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• yttrium-90 radioembolization — COMBINATION_PRODUCT
  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 Details

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.

Key Dates

Start date

Apr 7, 2025

Status verified

Apr 2025

Primary completion

Sep 1, 2026

Completion

Sep 1, 2029

Study Design

Enrollment

18 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: yttriuM-90 in combination with capEcitabine and aTezolizumab
  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

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 ]

Central Contacts

• Brown University Oncology Research Group (BrUOG)
  401-863-3000
  [email protected]
• Alexander G Raufi, MD
  401-787-0988
  [email protected]

Locations (1)

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