NCT06079242

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: GrandPharma (China) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	Resin microspheres containing yttrium-90 (Y-90)	SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only

Timeline

• Start date: 2023-10-15
• Primary completion: 2026-12-30
• Completion: 2027-04-01
• First posted: 2023-10-12
• Last updated: 2023-10-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study