Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin microspheres containing yttrium-90 (Y-90) | Device | SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver-specific overall response rate (ORR) according to RECIST 1.1 | Percentage of subjects with complete or partial responses to the liver as determined by the investigator according to liver-specific RECIST 1.1 criteria | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From the day of treatment with yttrium [90Y] resin microspheres to the time of death due to any cause | 24 months |
| 1-yr OS | The percentage of subjects treated with yttrium [90Y] resin microspheres who survived at 1 year. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Special contraindications from package insert, which includes
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
Not provided
Not provided
Not provided
Unresectable metastatic liver tumors from primary colorectal cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Wen, B.S. | Contact | 027-84399665 | huiwen@grandpharma.cn | |
| xixi Hu, MS | Contact | 027-84399665 | huxx@grandpharma.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310002 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| Progression-free survival(PFS) assessed by the investigator | Defined as the time from the date of treatment with the yttrium [90Y] resin microspheres to the time when disease progression or subject death from any cause during the study period was first determined by the investigator according to RECIST 1.1 criteria, whichever occurred first. | 24 months |
| Liver-specific PFS assessed by the investigator | Defined as the time from the date of treatment with yttrium [90Y] resin microspheres until the first time progression of liver disease or death of the subject from any cause during the study period was determined by the investigator according to liver-specific RECIST 1.1 criteria, whichever occurred first. | 24 months |
| ORR assessed by the investigator | Defined as the percentage of subjects with complete or partial tumor response as determined by the investigator according to RECIST 1.1 criteria | 24 months |
| Objective Duration of tumor response (DOR) assessed by the investigator | Defined as the time from the first documented objective response to tumor recurrence or death from any cause during the study period as determined by the investigator according to RECIST 1.1 criteria, whichever occurs first | 24 months |
| Duration of liver-specific DOR assessed by the investigator | Defined as the time from the first documented liver objective remission to liver recurrence or death from any cause during the study period as determined by the investigator according to liver-specific RECIST 1.1 criteria, whichever occurs first | 24 months |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided