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

Recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: SIRT with Yttrium-90 Microspheres; Drug: FOLFIRI and Bevacizumab

• Registration Number: NCT06447727
• Lead Sponsor: Zhongda Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2024-05-20
• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival(PFS)	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.	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.

Secondary Outcome Measures

Name	Time	Method
Hepatic progression-free survival (hPFS)	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.	defined as the time between the date of initiation of treatment with FOLFIRI and the date of progression on liver imaging or death from any cause, whichever occurs first. Assessed according to RECIST 1.1 criteria.
Overall survival (OS)	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.	defined as the time between the date of initiation of treatment with FOLFIRI and the date of death due to any cause.
Safety(adverse events)	within 6 months from the start of SIRT treatment.	Incidence of grade 3 and above adverse events (NCI-CTCAE v5.0) within 6 months from the start of SIRT treatment.
Objective response rate（ORR）	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.	defined as the time between the date of initiation of treatment with FOLFIRI and the date of radiographic progression or death from any cause, whichever occurs first. According to RECIST 1.1 criteria.
Disease control rate (DCR) for target lesions	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.	defined as the proportion of subjects who achieve optimal tumor response or stable disease (complete response, partial response, or stable disease) over the course of the study. Assessed according to RECIST 1.1 criteria.
Conversion resection rate	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.	the proportion of participants who underwent successful surgical resection of unresectable CRLM after receiving SIRT in combination with FOLFIRI and bevacizumab.

Trial Locations

Locations (1)

Zhongda Hospital，Southeast University; 🇨🇳 Nanjing, Jiangsu, China