Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

845 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-19

Study Completion Date

2029-06-30

Brief Summary

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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

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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.

Conditions

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Unresectable Hepatocellular Carcinoma (HCC) Liver Metastases From Colorectal Cancer (mCRC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with unresectable HCC or unresectable liver metastases from mCRC

This cohort will include patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, who have been prescribed selective internal radiation therapy (SIRT) with SIR-Spheres per medical decision.

SIRT

Intervention Type DEVICE

Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.

Interventions

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SIRT

Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Beaujon

Clichy, Cedex, France

Site Status RECRUITING