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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Hui Wen, B.S.; Phone Number: 027-84399665; Email: huiwen@grandpharma.cn
• Study Contact Backup: Name: xixi Hu, MS; Phone Number: 027-84399665; Email: huxx@grandpharma.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310002
      • Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
      • Principal Investigator: hongming Pan, PhD
      • Contact: hongming Pan, PhD; Phone Number: 0571-86006922; Email: shonco@sina.cn
      • Contact: weidong Han, PhD; Phone Number: 0571-86006922; Email: hanwd@zju.edu.cn
      • Sub-Investigator: weidong Han, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Unresectable metastatic liver tumors from primary colorectal cancer

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: GrandPharma (China) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Metastatic Colorectal Cancer; SIRT; 90Y; Liver Metastases; Radioembolization; SIR-Spheres Microspheres
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ST-GPL00102-CP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No