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

Grand Pharmaceutical Group

Status: Not yet enrolling

Conditions: Colorectal Neoplasms

Treatments: Device: Resin microspheres containing yttrium-90 (Y-90)

Study type: Observational

Funder types: Industry

Identifiers

NCT06079242

ST-GPL00102-CP001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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