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

Zhongda Hospital30 enrolled

Overview

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

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

Conditions

Colorectal Cancer Metastatic

Interventions

SIRT with Yttrium-90 MicrospheresDRUG

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

FOLFIRI and BevacizumabDRUG

FOLFIRI and Bevacizumab

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongda Hospital，Southeast University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

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.