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

NCT06079242 · tracked via the Priya Life Science China tracker

Sponsor

GrandPharma (China) Co., Ltd.

Phase

Observational

Started

2023-10-15

Last updated

2023-10-13

Condition(s) studied

Colorectal Neoplasms

Investigational drug(s) / intervention(s)

Resin microspheres containing yttrium-90 (Y-90)

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Liver-specific overall response rate (ORR) according to RECIST 1.1 — 24 months
Percentage of subjects with complete or partial responses to the liver as determined by the investigator according to liver-specific RECIST 1.1 criteria

Trial sites (1)

Facility	City	Region	Status
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06079242 on ClinicalTrials.gov ↗ ← All trials in China