Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of CRLM
NCT ID: NCT06447727
Last Updated: 2024-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-05-20
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
SIRT with Yttrium-90 Microspheres
Selective Internal Radiation Therapy (SIRT) with Yttrium-90 \[90Y\] Microspheres Injection
FOLFIRI and Bevacizumab
FOLFIRI and Bevacizumab
Interventions
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SIRT with Yttrium-90 Microspheres
Selective Internal Radiation Therapy (SIRT) with Yttrium-90 \[90Y\] Microspheres Injection
FOLFIRI and Bevacizumab
FOLFIRI and Bevacizumab
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Zhongda Hospital
OTHER
Responsible Party
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Gao-jun Teng
Dean
Principal Investigators
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Gao-Jun Teng
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Locations
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Zhongda Hospital，Southeast University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Hai-Dong Zhu
Role: primary
Other Identifiers
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ST-Y90-CP01
Identifier Type: -
Identifier Source: org_study_id
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