Clinical trial NCT06447727: Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of CRLM
Official title: Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of Colorectal Cancer Liver Metastasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer Metastatic
Keywords: Yttrium[90Y]
colorectal cancer liver metastases, CRLM
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver metastasis of colorectal cancer

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.

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

Primary outcomes:
measure: Progression-Free Survival(PFS)
timeFrame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Secondary outcomes:
measure: Objective response rate（ORR）
timeFrame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
measure: Disease control rate (DCR) for target lesions
timeFrame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
measure: Conversion resection rate
timeFrame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
measure: Hepatic progression-free survival (hPFS)
timeFrame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
measure: Overall survival (OS)
timeFrame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
measure: Safety(adverse events)
timeFrame: within 6 months from the start of SIRT treatment.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital，Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng
role: PRINCIPAL_INVESTIGATOR
References: