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

Colorectal Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06447727
• Other study ID #: ST-Y90-CP01
• Status: Recruiting
• Start date: May 20, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: June 2024
• Source: Zhongda Hospital
• Contact: Hai-Dong Zhu
• Phone: +86-25-83272121
• Email: zhuhaidong9509[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• SIRT with Yttrium-90 Microspheres
Selective Internal Radiation Therapy (SIRT) with Yttrium-90 [90Y] Microspheres Injection
• FOLFIRI and Bevacizumab
FOLFIRI and Bevacizumab

Locations

Country	Name	City	State
China	Zhongda Hospital,Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Secondary	Objective response rate(ORR)	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.	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Secondary	Disease control rate (DCR) for target lesions	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.	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Secondary	Conversion resection rate	the proportion of participants who underwent successful surgical resection of unresectable CRLM after receiving SIRT in combination with FOLFIRI and bevacizumab.	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Secondary	Hepatic progression-free survival (hPFS)	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.	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Secondary	Overall survival (OS)	defined as the time between the date of initiation of treatment with FOLFIRI and the date of death due to any cause.	until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Secondary	Safety(adverse events)	Incidence of grade 3 and above adverse events (NCI-CTCAE v5.0) within 6 months from the start of SIRT treatment.	within 6 months from the start of SIRT treatment.