NCT03292991

REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.

Detailed description

All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively. 1. Primary objective: * To observe the safety of SIR-Spheres® microspheres therapy (SIRT)by, * Adverse events and serious adverse events (non-specific and radiation specific) * Changes in liver function parameters * To observe the efficacy of SIR-Spheres® microspheres therapy by, assessing the best overall response rate after SIRT 2. Secondary objectives: * To observe the efficacy of SIRT by, * Overall survival (OS) * Overall/objective response rate (ORR) * Time-to-progression * Time-to-liver progression * Progression-free survival * To observe the changes in clinical presentation after SIRT by, * ECOG score * Child-Pugh score * Percentage of subjects with down-staging or down-sizing of treated lesion to resection, transplantation, or radiofrequency ablation (RFA) * To observe the practice pattern of SIRT by, * Median dosage (GBq) * Number of SIRT sessions received by subjects 3. Exploratory objectives: * To explore prognostic factors for disease progression after SIRT by comparing the following parameters: * Number of tumors in subjects prior to SIRT * Median tumor size in subjects prior to SIRT * Location of tumor in subjects treated with SIRT (hepatic segment or lobe) * Number of prior TACE treatment in subjects * Antiviral therapy subjects HCC

Conditions

• Hepatocellular Carcinoma

Timeline

• Start date: 2015-06-09
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-09-26
• Last updated: 2017-09-26

Locations

1 site across 1 country: Taiwan