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

Sponsor

GrandPharma (China) Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06079242

Collaborator

(none)

200

Enrollment

Location

41.5

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms	Device: Resin microspheres containing yttrium-90 (Y-90)

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Dec 30, 2026

Anticipated Study Completion Date :

Apr 1, 2027

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS) [24 months]
From the day of treatment with yttrium [90Y] resin microspheres to the time of death due to any cause
1-yr OS [12 months]
The percentage of subjects treated with yttrium [90Y] resin microspheres who survived at 1 year.
Progression-free survival(PFS) assessed by the investigator [24 months]
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.
Liver-specific PFS assessed by the investigator [24 months]
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.
ORR assessed by the investigator [24 months]
Defined as the percentage of subjects with complete or partial tumor response as determined by the investigator according to RECIST 1.1 criteria
Objective Duration of tumor response (DOR) assessed by the investigator [24 months]
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
Duration of liver-specific DOR assessed by the investigator [24 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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