Clinical trial NCT05967143: Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
Official title: Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unresectable Hepatocellular Carcinoma (HCC)
Liver Metastases From Colorectal Cancer (mCRC)
Keywords: Liver metastases from colorectal cancer (mCRC)
Unresectable Hepatocellular carcinoma (HCC)
SIR-Spheres microspheres
Y-90 resin microspheres
SIRT
Lead sponsor: Sirtex Medical
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 845
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a Primary Care Clinic.

Brief summary: This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres

Detailed description: This is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with SIR-Spheres per medical decision.

The study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Confirmed diagnosis of:
* Unresectable hepatocellular carcinoma (HCC) Or
* Unresectable liver metastases from colorectal cancer (mCRC) refractory to or intolerant to chemotherapy
* Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice
* Planned to receive SIR-Spheres treatment to the liver for the first time
* Provision of signed patient informed consent

Exclusion Criteria:

* Prior radiation treatment to the liver

Caveat:

Sequential selective internal radiation therapy (SIRT) treatment is allowed

* Patients participating in any interventional clinical trial with an investigational product, device, or procedure
* Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 24months from LPI
measure: Liver PFS (LPFS)
timeFrame: 24months from LPI
measure: Overall survival (OS)
timeFrame: 24months from LPI
measure: Objective response rate (ORR) and liver response rate (LRR)
timeFrame: 24months from LPI
measure: Duration of response (DoR)
timeFrame: 24months from LPI
measure: Change scores from baseline to follow-up timepoints of the EQ-5D-5L
timeFrame: 24months from LPI
measure: Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30)
timeFrame: 24months from LPI
measure: Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Hepatocellular Carcinoma module (EORTC QLQ-HCC18)
timeFrame: 24months from LPI
Secondary outcomes:
measure: SAEs/SADE's rates
timeFrame: 24months from LPI
measure: Subsequent hepatic procedures summarized at follow-up timepoints
timeFrame: 24months from LPI
measure: Healthcare Resource Utilization summarized at follow-up timepoints
timeFrame: 24months from LPI
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon
state: Cedex
city: Créteil
country: France
facility: Hopital Henri Mondor
state: Paris
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud
state: Rhône
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Manchester
country: United Kingdom
facility: The Christie Hospital
state: Lancashire
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
References: