AzTrials
AzTrials

Unresectable Hepatocellular CarcinomaDOORwaY90NCT04736121

Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

A study testing Resin microspheres containing yttrium-90 (Y-90) in people with Unresectable Hepatocellular Carcinoma and BCLC Stage A Hepatocellular Carcinoma, run by Sirtex Medical at 22 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resin microspheres containing yttrium-90 (Y-90)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
22 sitesUnited States
Study dates
28 May 2021to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing, able, and mentally competent to provide written informed consent
  • Age 18 or older at the time of consent
  • All tumors must be measurable by CT or MRI according to localized mRECIST
  • Life expectancy ≥ 6 months (to allow for adequate completion of study procedures and collection of data)
  • Diagnosis of HCC with Liver Imaging Reporting and Data System (LIRADS) 4 or 5 or by histology
  • Treatment-naïve patients or patients who have developed a new lesion following one of these prior locoregional treatments:
Show all 23Show fewer
  • Liver resection with negative pathologic margins, no microvascular invasion, and no recurrence at resection margins for at least 6 months post-treatment and no new lesions within 6 months of liver resection
  • Ablation of a single ≤3cm lesion with no recurrence of the treated lesion for at least 6 months post-treatment
  • BCLC stage A, B1, B2, and C with maximal single tumor size of ≤8 cm and sum of the maximal tumor dimensions of ≤12 cm with the entire tumor burden expected to be treatable within the perfused volume
  • At least one lesion ≥1 cm in diameter (long axis) measured according to mRECIST criteria by CT or MRI
  • Child-Pugh score of A5 or A6 at baseline
  • Eastern Cooperative Oncology Group (ECOG) performance score of ≤1 at baseline
  • Adequate blood count, liver enzymes, and renal function at baseline
  • Platelet count >50,000/microliter (patients may not receive a platelet transfusion or growth factors to increase the platelet count so that the patient may be eligible for the study)
  • White Blood Cell (WBC) ≥ 3 x 10^9/L
  • Hemoglobin > 8.5 g/dL
  • Aspartate transaminase (AST) \& Alanine transaminase (ALT) < 5 x upper limit normal
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin > 3.0 g/dL
  • International normalized ratio (INR) ≤ 2.0
  • Glomerular filtration rate (GFR) > 50
  • Negative serum pregnancy test at baseline
  • Life expectancy of > 3 months without any active treatment

Who cannot join

  • Patients eligible for ablation or resection for their malignancy, in the opinion of the investigator, at the time of screening
  • Prior systemic anti-cancer therapy (including immunotherapy and/or targeted therapy), radiotherapy or use of other investigational agents for the treatment of HCC
  • Intrahepatic arteriovenous shunting (arteriovenous shunting resulting from a biopsy is allowed but must be embolized during the pre-treatment mapping procedure)
  • Incompetent biliary duct system, prior biliary intervention or a compromised Ampulla of Vater
  • Planned localized cancer treatment to the liver, other than the study treatment, throughout the duration of the study.
  • Planned systemic cancer treatment throughout the duration of the study
Show all 24Show fewer
  • Patients with portal vein thrombosis
  • Patients with extrahepatic disease
  • Patients with contraindications to angiography and selective visceral catheterization
  • Evidence of extrahepatic collateral supply to the tumor
  • Evidence of potential delivery of mean radiation dose > 30 Gy to the lungs (single treatment)
  • Evidence of any detectable 99m Tc-macroaggregated albumin (99m Tc-MAA) flow outside of the liver in the abdomen, after application of established angiographic techniques to stop or mitigate such flow (e.g., placing catheter distal to gastric vessels or coiling)
  • Evidence that < 33% of the total liver volume is disease-free and will be spared SIR-Spheres treatment
  • Prior liver resection and/or liver transplant, with exception for patients with prior resection who meet inclusion criterion 6a
  • Female patients who are pregnant, breastfeeding, or premenopausal and unwilling to use an effective method of contraception through the 1-year follow-up; males unwilling to use effective method of contraception for 30 days post-procedure
  • Medical history of clotting disorders
  • Underlying pulmonary disease requiring chronic oxygen therapy
  • Evidence of portal hypertension with ascites as seen on cross-sectional imaging or any history of prior variceal bleeding within 6 months prior to screening
  • Concurrently enrolled in another study unless it is an observational, noninterventional study
  • Active infection (hepatitis B (HBV) infection with ongoing HBV treatment and successfully treated hepatitis C infection are allowed)
  • History of other cancer with current active treatment
  • Patients with drug or alcohol dependency (within 6 months prior to study entry) in the opinion of the investigator
  • History of severe allergy or intolerance to contrast agents, narcotics, or sedatives
  • Any condition that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of North Carolina - Chapel Hill Medical Center

    Chapel Hill, North Carolina, 27599

  • University of Cincinnati Cancer Center CTO

    Cincinnati, Ohio, 45267

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Clinical Research Institute and Methodist Hospital

    Dallas, Texas, 75203

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California Los Angeles - Ronald Reagan Medical Center

    Los Angeles, California, 90095

  • Miami Cardiac and Vascular Institute at Baptist Hospital

    Miami, Florida, 33176

  • Columbia University CUIMC/NYPH

    New York, New York, 10032

  • Providence St. Joseph Hospital

    Orange, California, 92868

  • University of California Irvine

    Orange, California, 92868

  • Hospital of the University Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239

  • Inland Imaging

    Spokane, Washington, 99208

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C.

SIR-Spheres consist of biocompatible resin microspheres containing yttrium-90 (Y-90), with a size between 20 and 60 microns in diameter. Y-90 is a high-energy pure beta-emitting isotope with no primary gamma emission.

SIR-Spheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2, maximal single lesion size of 8 cm, no macrovascular invasion, well-compensated liver function and good performance status. It is also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of Floxuridine (FUDR).

Read the detailed description

The investigation is a pivotal, prospective, multicenter, open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.

Up to 100 subjects will be treated (up to 150 consented) at up to 30 clinical sites in the United States.

The population for this study includes patients diagnosed with HCC BCLC stage A, B1, B2, and C with maximal single lesion size of ≤ 8cm and who are not considered suitable for treatment by resection or eligible for ablation at time of study entry.

Being tested
Resin microspheres containing yttrium-90 (Y-90)
Keywords
Unresectable hepatocellular carcinoma, HCC, Unresectable metastatic liver tumor, SIR-Spheres microspheres, Y-90 resin microspheres, Barcelona Clinic Liver Cancer, BCLC, SIRT (Selective Internal Radiation Therapy), Liver cancer
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resin microspheres containing yttrium-90 (Y-90)Device

    Biocompatible resin microspheres are an injectable permanent implant and preferentially placed into the distal microvascular supply of tumors to provide direct irradiation of tissue and destruction of the microvascular bed. Spheres contain yttrium-90 (Y-90) and are a size between 20 and 60 microns in diameter.

Study groups in NCT04736121
Study groupRoleWhat they receive
Open-label Single ArmExperimentalOpen-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.
Receives: Device: Resin microspheres containing yttrium-90 (Y-90)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    ORR uses a localized version of modified Response Evaluation Criteria in Solid Tumors ("localized mRECIST") criteria and best response through 9 months, in patients treated with SIR-Spheres Y-90 resin microspheres.

    Measured: 9 months

  2. Duration of Response (DoR)

    The interval from first time of response (complete response (CR) or partial response (PR)) until disease progression (PD) as defined by localized mRECIST criteria.

    Measured: 12 months

Secondary outcomes (5)

  1. Grade ≥ 3 toxicity (CTCAE v5.0)

    The severity of the adverse event should be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: 2 months and 6 months

  2. Incidence of liver resection

    Liver resection as noted on follow-up case report form.

    Measured: Post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months

  3. Incidence of liver transplant

    Liver transplant as noted on follow-up case report form.

    Measured: Post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months

  4. Quality of life metrics - FACT-Hep Questionnaire

    Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire

    Measured: Pre-procedure, 2, 4, 6, 9, and 12 months

  5. Quality of life metrics - EQ-5D-5L Questionnaire

    EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire

    Measured: Pre-procedure, 2, 4, 6, 9, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start28 May 2021
  3. Primary completion14 Aug 2025
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A pivotal, prospective, multicenter, open-label single arm study
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736121
Sponsor's protocol ID
STX2001
Acronym
DOORwaY90
Status last verified
Jan 2026
First submitted
27 Jan 2021
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Mahvash A, Chartier S, Turco M, Habib P, Griffith S, Brown S, Kappadath SC. 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.

    PubMed 35346070

Questions about this trial

What is this clinical trial studying?

A study testing Resin microspheres containing yttrium-90 (Y-90) in people with Unresectable Hepatocellular Carcinoma and BCLC Stage A Hepatocellular Carcinoma, run by Sirtex Medical at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04736121, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in