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

NCT04736121 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STX2001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 22

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).

Conditions

Unresectable Hepatocellular Carcinoma; BCLC Stage A Hepatocellular Carcinoma; BCLC Stage B Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma

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

Outcome Measures

Primary Outcomes (2)

• 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.

  9 months

• 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.

  12 months

Secondary Outcomes (5)

• Grade ≥ 3 toxicity (CTCAE v5.0)

  2 months and 6 months

• Incidence of liver resection

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

• Incidence of liver transplant

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

• Quality of life metrics - FACT-Hep Questionnaire

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

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

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

Study Arms (1)

Open-label Single Arm

EXPERIMENTAL

Open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.

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

Interventions

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.

Open-label Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Sirtex Medical: lead
• Bright Research Partners: collaborator

Study Sites (22)

University of California Los Angeles - Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

Providence St. Joseph Hospital

Orange, California, 92868, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Miami Cardiac and Vascular Institute at Baptist Hospital

Miami, Florida, 33176, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Columbia University CUIMC/NYPH

New York, New York, 10032, United States

Location

University of North Carolina - Chapel Hill Medical Center

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Cancer Center CTO

Cincinnati, Ohio, 45267, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital of the University Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Clinical Research Institute and Methodist Hospital

Dallas, Texas, 75203, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Inland Imaging

Spokane, Washington, 99208, United States

Location

Related Publications (1)

• 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.

  PMID: 35346070 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Armeen Mahvash, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• S. Cheenu Kappadath, Ph.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A pivotal, prospective, multicenter, open-label single arm study

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 3, 2021
• Study Start: May 28, 2021
• Primary Completion: August 14, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)