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 : December 14, 2021
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|
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 10-15 clinical sites in the United States. No single site will enroll more than 20% of the total study enrollment.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A pivotal, prospective, multicenter, open-label single arm study|
|Masking:||None (Open Label)|
|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 :||October 2022|
|Estimated Study Completion Date :||March 2024|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
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
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