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

Southeast University

Status: Enrolling

Conditions: Colorectal Cancer Metastatic

Treatments: Drug: FOLFIRI and Bevacizumab; Drug: SIRT with Yttrium-90 Microspheres

Study type: Observational

Funder types: Other

Identifiers

NCT06447727

ST-Y90-CP01

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab

Description:

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

Treatment:

Drug: SIRT with Yttrium-90 Microspheres

Drug: FOLFIRI and Bevacizumab