Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer

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

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2027-04-01

Brief Summary

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This real-world study tries to collect data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable liver metastases from Metastatic Liver Tumors From Primary Colorectal Cancer (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 in China.

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Detailed Description

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This is a post-market trial evaluating the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. Patients enrolled should already complete the infusion of SIR-Spheres® and data are about to be collected both retrospectively and prospectively. 200 patients are anticipated to be enrolled and followed up for up to 24 months.

Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Resin microspheres containing yttrium-90 (Y-90)

SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only

Intervention Type DEVICE

Other Intervention Names

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SIR-Spheres® Y-90

Eligibility Criteria

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Inclusion Criteria

1. Obtained informed consent for patients to be follow-up prospectively
2. Age≥18 years old
3. Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
4. Received SIR-Spheres®

Exclusion Criteria

1. Special contraindications from package insert, which includes

1. Markedly abnormal liver function tests, such as total bilirubin \> 2.0 mg/dL or albumin \<3.0 g/dL
2. Portal vein thrombosis in the main trunk
3. Disseminated extrahepatic disease
4. Previous external beam radiation therapy to the liver
2. Women are lactating or pregnant during the study or plan to be pregnant during the study
3. Patients with mental illness or cognitive impairment
4. Per investigator, patients are non-adherent or reluctant to be followed up

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No