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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079242
• Other study ID #: ST-GPL00102-CP001
• Status: Not yet recruiting
• Start date: October 15, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: October 2023
• Source: GrandPharma (China) Co., Ltd.
• Contact: Hui Wen, B.S.
• Phone: 027-84399665
• Email: huiwen[@]grandpharma.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 1, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
GrandPharma (China) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Overall survival (OS)	From the day of treatment with yttrium [90Y] resin microspheres to the time of death due to any cause	24 months
Secondary	1-yr OS	The percentage of subjects treated with yttrium [90Y] resin microspheres who survived at 1 year.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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