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Trial Title:
Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
NCT ID:
NCT06079242
Condition:
Colorectal Neoplasms
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Metastatic Colorectal Cancer
90Y
Liver Metastases
SIRT
Radioembolization
SIR-Spheres Microspheres
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Device
Intervention name:
Resin microspheres containing yttrium-90 (Y-90)
Description:
SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only
Other name:
SIR-Spheres® Y-90
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.
Criteria for eligibility:
Study pop:
Unresectable metastatic liver tumors from primary colorectal cancer
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310002
Country:
China
Contact:
Last name:
hongming Pan, PhD
Phone:
0571-86006922
Email:
shonco@sina.cn
Contact backup:
Last name:
weidong Han, PhD
Phone:
0571-86006922
Email:
hanwd@zju.edu.cn
Investigator:
Last name:
hongming Pan, PhD
Email:
Principal Investigator
Investigator:
Last name:
weidong Han, PhD
Email:
Sub-Investigator
Start date:
October 15, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
GrandPharma (China) Co., Ltd.
Agency class:
Industry
Source:
GrandPharma (China) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06079242
