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Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (DOORwaY90)

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ClinicalTrials.gov Identifier: NCT04736121
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : March 20, 2024
Sponsor:
Collaborator:
Bright Research Partners
Information provided by (Responsible Party):
Sirtex Medical

Study Description
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Brief 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.

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).


Condition or disease Intervention/treatment Phase
Unresectable Hepatocellular Carcinoma BCLC Stage A Hepatocellular Carcinoma BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Device: Resin microspheres containing yttrium-90 (Y-90) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A pivotal, prospective, multicenter, open-label single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open-label Single Arm
Open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.
 Device: Resin microspheres containing yttrium-90 (Y-90)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 9 months ]
    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.

  2. Duration of Response (DoR) [ Time Frame: 12 months ]
    The interval from first time of response (complete response (CR) or partial response (PR)) until disease progression (PD) as defined by localized mRECIST criteria.


Secondary Outcome Measures :
  1. Grade ≥ 3 toxicity (CTCAE v5.0) [ Time Frame: 2 months and 6 months ]
    The severity of the adverse event should be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  2. Incidence of liver resection [ Time Frame: Post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months ]
    Liver resection as noted on follow-up case report form.

  3. Incidence of liver transplant [ Time Frame: Post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months ]
    Liver transplant as noted on follow-up case report form.

  4. Quality of life metrics - FACT-Hep Questionnaire [ Time Frame: Pre-procedure, 2, 4, 6, 9, and 12 months ]
    Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire

  5. Quality of life metrics - EQ-5D-5L Questionnaire [ Time Frame: Pre-procedure, 2, 4, 6, 9, and 12 months ]
    EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing, able, and mentally competent to provide written informed consent
  2. Age 18 or older at the time of consent
  3. All tumors must be measurable by CT or MRI according to localized mRECIST
  4. Life expectancy ≥ 6 months (to allow for adequate completion of study procedures and collection of data)
  5. Diagnosis of HCC with Liver Imaging Reporting and Data System (LIRADS) 4 or 5 or by histology

  6. Treatment-naïve patients or patients who have developed a new lesion following one of these prior locoregional treatments:

    1. 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
    2. Ablation of a single ≤3cm lesion with no recurrence of the treated lesion for at least 6 months post-treatment
  7. 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
  8. At least one lesion ≥1 cm in diameter (long axis) measured according to mRECIST criteria by CT or MRI
  9. Child-Pugh score of A5 or A6 at baseline
  10. Eastern Cooperative Oncology Group (ECOG) performance score of ≤1 at baseline

  11. Adequate blood count, liver enzymes, and renal function at baseline

    1. 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)
    2. White Blood Cell (WBC) ≥ 3 x 10^9/L
    3. Hemoglobin > 8.5 g/dL
    4. Aspartate transaminase (AST) & Alanine transaminase (ALT) < 5 x upper limit normal
    5. Bilirubin ≤ 2.0 mg/dL
    6. Albumin > 3.0 g/dL
    7. International normalized ratio (INR) ≤ 2.0
    8. Glomerular filtration rate (GFR) > 50
  12. Negative serum pregnancy test at baseline
  13. Life expectancy of > 3 months without any active treatment

Exclusion Criteria:

  1. Patients eligible for ablation or resection for their malignancy, in the opinion of the investigator, at the time of screening
  2. Prior systemic anti-cancer therapy (including immunotherapy and/or targeted therapy), radiotherapy or use of other investigational agents for the treatment of HCC
  3. Intrahepatic arteriovenous shunting (arteriovenous shunting resulting from a biopsy is allowed but must be embolized during the pre-treatment mapping procedure)
  4. Incompetent biliary duct system, prior biliary intervention or a compromised Ampulla of Vater
  5. Planned localized cancer treatment to the liver, other than the study treatment, throughout the duration of the study.
  6. Planned systemic cancer treatment throughout the duration of the study
  7. Patients with portal vein thrombosis
  8. Patients with extrahepatic disease
  9. Patients with contraindications to angiography and selective visceral catheterization
  10. Evidence of extrahepatic collateral supply to the tumor
  11. Evidence of potential delivery of mean radiation dose > 30 Gy to the lungs (single treatment)
  12. 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)
  13. Evidence that < 33% of the total liver volume is disease-free and will be spared SIR-Spheres treatment
  14. Prior liver resection and/or liver transplant, with exception for patients with prior resection who meet inclusion criterion 6a
  15. 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
  16. Medical history of clotting disorders
  17. Underlying pulmonary disease requiring chronic oxygen therapy
  18. 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
  19. Concurrently enrolled in another study unless it is an observational, noninterventional study
  20. Active infection (hepatitis B (HBV) infection with ongoing HBV treatment and successfully treated hepatitis C infection are allowed)
  21. History of other cancer with current active treatment
  22. Patients with drug or alcohol dependency (within 6 months prior to study entry) in the opinion of the investigator
  23. History of severe allergy or intolerance to contrast agents, narcotics, or sedatives
  24. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736121


Contacts
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Contact: Janet Bell 781-721-3840 jbell@sirtex.com

Locations
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Sponsors and Collaborators
Sirtex Medical
Bright Research Partners
Investigators
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Principal Investigator: Armeen Mahvash, M.D. M.D. Anderson Cancer Center
Principal Investigator: S. Cheenu Kappadath, Ph.D. M.D. Anderson Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT04736121    
Other Study ID Numbers: STX2001
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Sirtex Medical:
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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases