Combining Yttrium-90 microspheres with chemotherapy for colorectal cancer liver metastases

Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of Colorectal Cancer Liver Metastasis

This study is testing if combining a special type of radiation treatment with chemotherapy can help people with colorectal cancer that has spread to the liver feel better and live longer after their first treatment didn't work.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhongda Hospital (Academic / other)
• Drugs / interventions: bevacizumab, radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06447727 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to evaluate the efficacy and safety of selective internal radiation therapy (SIRT) using yttrium-90 microsphere injections in conjunction with FOLFIRI and bevacizumab for patients with colorectal cancer liver metastases who have progressed after first-line treatment. The study will monitor progression-free survival (PFS) among participants receiving this combined treatment approach. It is a multicenter study, indicating collaboration across multiple sites to gather comprehensive data on treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with liver metastases from colorectal cancer who have experienced progression after first-line therapy and are eligible for yttrium-90 microsphere injection.

Not a fit: Patients with extensive liver metastases or those who do not meet the specific eligibility criteria, such as poor organ function or certain genetic mutations, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could improve survival rates and quality of life for patients with colorectal cancer liver metastases.

How similar studies have performed: While this approach is innovative, similar studies using SIRT in combination with chemotherapy have shown promising results in treating liver metastases.

Eligibility criteria

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

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital，Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Gao-Jun Teng — Zhongda Hospital
• Study coordinator: Hai-Dong Zhu

Conditions Colorectal Cancer Metastatic; Yttrium[90Y]; colorectal cancer liver metastases, CRLM