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Recruiting NCT04390724

Optimizing Y90 Therapy for Radiation Lobectomy

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Trial Parameters

Condition HCC
Sponsor Northwestern University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 104
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-07-17
Completion 2026-07
Interventions
Y90 radioembolization

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Brief Summary

HCC resection candidates with inadequate future liver remnant will be enrolled in this study. They will be treated with Y90 radioembolization to help grow the liver enough to undergo liver resection. There will be 2 Patient Groups. The first group of patients will be treated with Y90 dose and embolic load as per standard-of-care. The second group of patients will be treated with the optimal Y90 dose and embolic load found in Patient Group 1.

Eligibility Criteria

Inclusion Criteria: 1. Patients must have been diagnosed with HCC confirmed by histology or must meet one of the following American Association for the Study of Liver Diseases (AASLD) guidelines: * AFP \>200 and radiological evidence (arterial hypervascularity) of lesion \> 2 cm does not require biopsy * Two imaging modalities (triphasic CT, MRI, ultrasound, angiography) demonstrating arterial hypervascularity in the background of cirrhosis does not require biopsy * One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy 2. Child-Pugh stage A 3. Future Liver Remnant (FLR) of \< 40% 4. ECOG Performance Status 0-1 5. Bilirubin ≤ 3.0 mg/dl- Treatment may proceed if the Bilirubin is elevated if the tumor may be isolated from a vascular standpoint 6. Creatinine ≤ 2.0 mg/dl 7. ANC ≥ 1.5 K/uL 8. Platelets \> 25 K/uL 9. Patient is willing participate in this study and has signed the consent 10. For Group 2 pati

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