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

NCT06079242 | Not Yet Recruiting FDA Device

• 1 other identifier: ST-GPL00102-CP001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

Metastatic Colorectal Cancer; 90Y; Liver Metastases; SIRT; Radioembolization; SIR-Spheres Microspheres

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall survival (OS)

  24 months

• 1-yr OS

  12 months

• Progression-free survival(PFS) assessed by the investigator

  24 months

• Liver-specific PFS assessed by the investigator

  24 months

• ORR assessed by the investigator

  24 months

Interventions

Resin microspheres containing yttrium-90 (Y-90) DEVICE

SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only

Also known as: SIR-Spheres® Y-90

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unresectable metastatic liver tumors from primary colorectal cancer

You may qualify if:

• 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®

You may not qualify if:

• 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

Sponsors & Collaborators

• GrandPharma (China) Co., Ltd.: lead

Study Sites (1)

Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310002, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Hui Wen, B.S.

CONTACT

027-84399665; huiwen@grandpharma.cn

xixi Hu, MS

CONTACT

027-84399665; huxx@grandpharma.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 12, 2023
• Study Start: October 15, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

CN (1)