Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of CRLM

June 3, 2024 updated by: Gao-jun Teng, Zhongda Hospital

Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of Colorectal Cancer Liver Metastasis

To observe the PFS of yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab in second-line treatment of CRLM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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 study is a prospective, multicenter, observational, cohort study to observe the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab as second-line therapy in patients with colorectal cancer liver metastases.

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.
30

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 Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital，Southeast University
        • Contact:
          • Hai-Dong Zhu

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

Patients with liver metastasis of colorectal cancer

Description

Inclusion Criteria:

  1. 18 years old≤ age ≤ 75 years old
  2. Voluntarily signed informed consent
  3. Patients with liver metastases of colorectal cancer, colorectal cancer lesions have resection, liver metastases limited to a single lobe
  4. The liver tumor progresses after first-line treatment, and FOLFIRI combined with bevacizumab therapy is planned
  5. On the assessment of the clinician, the patient was eligible for yttrium [90Y] microspheres injection, and treatment with yttrium [90Y] microspheres injection was planned
  6. KRAS mutant
  7. ECOG PS: 0-1
  8. Child Pugh score ≤7
  9. Adequate level of organ function：a) Hematology: Neutrophils (ANC) ≥1.5×109/L, hemoglobin (HB) ≥90 g/L, platelets (PLT) ≥75×109/L；b) Liver function: albumin > 3 g/dL; ALT and AST≤ 5 x ULN; TBIL < 34.0 μmol/L；c) Renal function: serum creatinine ≤176.8 μmol/L or endogenous creatinine clearance > 50 mL/min；d) Coagulation function: INR≤1.2.

Exclusion Criteria:

  1. After liver metastasis was diagnosed, the liver underwent external radiation therapy and transhepatic arterial chemoembolization
  2. Patients with extrahepatic metastases
  3. Pregnant and lactating women
  4. History of severe arrhythmia or heart failure
  5. Other researchers considered it inappropriate to participate in this study

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab
Selective Internal Radiation Therapy (SIRT) with Yttrium-90 [90Y] Microspheres Injection combined with FOLFIRI and Bevacizumab
Drug: SIRT with Yttrium-90 Microspheres
Selective Internal Radiation Therapy (SIRT) with Yttrium-90 [90Y] Microspheres Injection
Drug: FOLFIRI and Bevacizumab
FOLFIRI and Bevacizumab

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
Progression-Free Survival(PFS)
Time Frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Defined as the time from the start of FOLFIRI treatment to the date of radiographic progression or death due to any cause, whichever occurs first, based on RECIST 1.1 criteria.
until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.

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
Objective response rate（ORR）
Time Frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
defined as the time between the date of initiation of treatment with FOLFIRI and the date of radiographic progression or death from any cause, whichever occurs first. According to RECIST 1.1 criteria.
until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Disease control rate (DCR) for target lesions
Time Frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
defined as the proportion of subjects who achieve optimal tumor response or stable disease (complete response, partial response, or stable disease) over the course of the study. Assessed according to RECIST 1.1 criteria.
until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Conversion resection rate
Time Frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
the proportion of participants who underwent successful surgical resection of unresectable CRLM after receiving SIRT in combination with FOLFIRI and bevacizumab.
until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Hepatic progression-free survival (hPFS)
Time Frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
defined as the time between the date of initiation of treatment with FOLFIRI and the date of progression on liver imaging or death from any cause, whichever occurs first. Assessed according to RECIST 1.1 criteria.
until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Overall survival (OS)
Time Frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
defined as the time between the date of initiation of treatment with FOLFIRI and the date of death due to any cause.
until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Safety(adverse events)
Time Frame: within 6 months from the start of SIRT treatment.
Incidence of grade 3 and above adverse events (NCI-CTCAE v5.0) within 6 months from the start of SIRT treatment.
within 6 months from the start of SIRT treatment.

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.
Zhongda Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gao-Jun Teng, Zhongda Hospital

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 (Actual)

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.
May 20, 2024

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.
November 30, 2025

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.
November 30, 2025

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).
June 3, 2024

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.
June 3, 2024

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.
June 7, 2024

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.
June 7, 2024

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.
June 3, 2024

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.
June 1, 2024

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-Y90-CP01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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