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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 18 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.

Locations
Other Locations
China
Zhongda Hospital,Southeast University
RECRUITING
Nanjing
Contact Information
Primary
Hai-Dong Zhu
zhuhaidong9509@163.com
+86-25-83272121
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Zhongda Hospital

This content was sourced from clinicaltrials.gov