A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of 90Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study

Armeen Mahvash; Steven Chartier; Mark Turco; Paula Habib; Steven Griffith; Scott Brown; S Cheenu Kappadath

doi:10.1186/s12876-022-02204-1

A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of ⁹⁰Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study

BMC Gastroenterol. 2022 Mar 28;22(1):151. doi: 10.1186/s12876-022-02204-1.

Authors

Armeen Mahvash¹, Steven Chartier², Mark Turco², Paula Habib², Steven Griffith², Scott Brown³, S Cheenu Kappadath⁴

Affiliations

¹ Department of Interventional Radiology, Unit 1471, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030, USA. armeen.mahvash@mdanderson.org.
² Sirtex, Woburn, MA, USA.
³ BRIGHT Research Partners, Minneapolis, MN, USA.
⁴ Department of Imaging Physics, University of Texas MD Anderson Cancer Center, 1155 Pressler Street, Unit 1352, Houston, TX, 77030, USA. skappadath@mdanderson.org.

Abstract

Background: Selective internal radiation therapy (SIRT) with yttrium-90 (⁹⁰Y) resin microspheres is an established locoregional treatment option for unresectable hepatocellular carcinoma (HCC), which delivers a lethal dose of radiation to hepatic tumors, while sparing surrounding healthy tissue. DOORwaY90 is a prospective, multicenter, open-label, single arm study, designed to evaluate the safety and effectiveness of ⁹⁰Y resin microspheres as first-line treatment in patients with unresectable/unablatable HCC. It is unique in that it is the first study with resin microspheres to utilize a personalized ⁹⁰Y dosimetry approach, and independent review for treatment planning and response assessment.

Methods: Eligibility criteria include unresectable/unablatable HCC, Barcelona Clinic Liver Cancer stage A, B1, B2, or C with a maximal single tumor diameter of ≤ 8 cm, and a sum of maximal tumor diameters of ≤ 12 cm, and at least one tumor ≥ 2 cm (long axis) per localized, modified Response Evaluation Criteria in Solid Tumors. Partition model dosimetry is used to determine the optimal dose; the target mean dose to tumor is ≥ 150 Gy. Patients are assessed at baseline and at regular intervals up until 12 months of treatment for response rates, safety, and quality of life (QoL). Post-treatment dosimetry is used to assess dose delivered to tumor and consider if retreatment is necessary. The co-primary endpoints are best objective response rate and duration of response. Secondary endpoints include grade ≥ 3 toxicity, QoL, and incidence of liver resection and transplantation post SIRT. Target recruitment is 100 patients.

Discussion: The results of this trial should provide further information on the potential use of SIRT with ⁹⁰Y resin microspheres as first-line therapy for unresectable HCC.

Trial registration: Clinicaltrials.gov; NCT04736121; date of 1st registration, January 27, 2021, https://clinicaltrials.gov/ct2/show/NCT04736121 .

Keywords: 90Y resin microspheres; Hepatocellular carcinoma (HCC); Radioembolization; SIRT.

Publication types

Multicenter Study

MeSH terms

Carcinoma, Hepatocellular* / pathology
Clinical Trials as Topic
Humans
Liver Neoplasms* / pathology
Microspheres
Prospective Studies
Quality of Life

Associated data

ClinicalTrials.gov/NCT04736121