Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resin microspheres containing yttrium-90 (Y-90).
- Who it may be relevant to
- Registry conditions: Colorectal Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Resin microspheres containing yttrium-90 (Y-90)
SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only
Primary outcome measures
- Liver-specific overall response rate (ORR) according to RECIST 1.1 [Time frame: 24 months]
Secondary outcome measures (7)
- Overall survival (OS) [Time frame: 24 months]
- 1-yr OS [Time frame: 12 months]
- Progression-free survival(PFS) assessed by the investigator [Time frame: 24 months]
- Liver-specific PFS assessed by the investigator [Time frame: 24 months]
- ORR assessed by the investigator [Time frame: 24 months]
- Objective Duration of tumor response (DOR) assessed by the investigator [Time frame: 24 months]
- Duration of liver-specific DOR assessed by the investigator [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Obtained informed consent for patients to be follow-up prospectively
- Age≥18 years old
- Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
- Received SIR-Spheres®
Exclusion criteria
- Special contraindications from package insert, which includes
- Markedly abnormal liver function tests, such as total bilirubin > 2.0 mg/dL or albumin <3.0 g/dL
- Portal vein thrombosis in the main trunk
- Disseminated extrahepatic disease
- Previous external beam radiation therapy to the liver
- Women are lactating or pregnant during the study or plan to be pregnant during the study
- Patients with mental illness or cognitive impairment
- Per investigator, patients are non-adherent or reluctant to be followed up
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medic — Hangzhou
Identifiers
NCT: NCT06079242 · ST-GPL00102-CP001