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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

Zhongda Hospital

Investigators

  • 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)

May 20, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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