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

October 11, 2023 updated by: GrandPharma (China) Co., Ltd.
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
        • Contact:
        • Sub-Investigator:
          • weidong Han, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Liver-specific overall response rate (ORR) according to RECIST 1.1
Time Frame: 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
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 24 months
From the day of treatment with yttrium [90Y] resin microspheres to the time of death due to any cause
24 months
1-yr OS
Time Frame: 12 months
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
Time Frame: 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.
24 months
Liver-specific PFS assessed by the investigator
Time Frame: 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.
24 months
ORR assessed by the investigator
Time Frame: 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
24 months
Objective Duration of tumor response (DOR) assessed by the investigator
Time Frame: 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
24 months
Duration of liver-specific DOR assessed by the investigator
Time Frame: 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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GrandPharma (China) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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