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

NCT06447727 | Recruiting FDA Drug

• 1 other identifier: ST-Y90-CP01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer Metastatic

Keywords

Yttrium[90Y]; colorectal cancer liver metastases, CRLM

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival(PFS)

  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 Outcomes (6)

• Objective response rate（ORR）

  until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.

• Disease control rate (DCR) for target lesions

  until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.

• Conversion resection rate

  until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.

• Hepatic progression-free survival (hPFS)

  until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.

• Overall survival (OS)

  until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.

Study Arms (1)

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; Drug: FOLFIRI and Bevacizumab

Interventions

SIRT with Yttrium-90 Microspheres DRUG

Selective Internal Radiation Therapy (SIRT) with Yttrium-90 \[90Y\] Microspheres Injection

SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab

FOLFIRI and Bevacizumab DRUG

FOLFIRI and Bevacizumab

SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver metastasis of colorectal cancer

You may qualify if:

• years old≤ age ≤ 75 years old
• Voluntarily signed informed consent
• Patients with liver metastases of colorectal cancer, colorectal cancer lesions have resection, liver metastases limited to a single lobe
• The liver tumor progresses after first-line treatment, and FOLFIRI combined with bevacizumab therapy is planned
• On the assessment of the clinician, the patient was eligible for yttrium \[90Y\] microspheres injection, and treatment with yttrium \[90Y\] microspheres injection was planned
• KRAS mutant
• ECOG PS: 0-1
• Child Pugh score ≤7
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital，Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Interventions

Sirtuins; Bevacizumab

Intervention Hierarchy (Ancestors)

Group III Histone Deacetylases; Histone Deacetylases; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; ADP Ribose Transferases; Pentosyltransferases; Glycosyltransferases; Transferases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Gao-Jun Teng

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai-Dong Zhu

CONTACT

+86-25-83272121; zhuhaidong9509@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: May 20, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CN (1)