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

ConditionsUnresectable Hepatocellular Carcinoma (HCC)Liver Metastases From Colorectal Cancer (mCRC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSirtex Medical

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

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

Disqualifiers

Prior radiation treatment to the liver

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.

Trial population

Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a Primary Care Clinic.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SIRT

    Device

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

Treatment groups

845 Participants
are divided into 1 treatment group
Group A: Patients with unresectable HCC or unresectable liver metastases from mCRC1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time frame
24months from LPI
2

Liver PFS (LPFS)

Time frame
24months from LPI
3

Overall survival (OS)

Time frame
24months from LPI
4

Objective response rate (ORR) and liver response rate (LRR)

Time frame
24months from LPI

Secondary outcomes

1

SAEs/SADE's rates

Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates

Time frame
24months from LPI
2

Subsequent hepatic procedures summarized at follow-up timepoints

Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints

Time frame
24months from LPI
3

Healthcare Resource Utilization summarized at follow-up timepoints

The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.

Time frame
24months from LPI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sirtex Medical

Lead sponsor

Source ClinicalTrials.gov
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