Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of Colorectal Cancer Liver Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-Free Survival(PFS)
研究概览
简要总结
To observe the PFS of yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab in second-line treatment of CRLM.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •After liver metastasis was diagnosed, the liver underwent external radiation therapy and transhepatic arterial chemoembolization
- •Patients with extrahepatic metastases
- •Pregnant and lactating women
- •History of severe arrhythmia or heart failure
- •Other researchers considered it inappropriate to participate in this study
研究组 & 干预措施
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
干预措施: SIRT with Yttrium-90 Microspheres (Drug)
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
干预措施: FOLFIRI and Bevacizumab (Drug)
结局指标
主要结局
Progression-Free Survival(PFS)
时间窗: 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.
次要结局
- Hepatic progression-free survival (hPFS)(until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.)
- Overall survival (OS)(until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.)
- Safety(adverse events)(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.)
- Disease control rate (DCR) for target lesions(until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.)
- Conversion resection rate(until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.)
研究者
Gao-jun Teng
Dean
Zhongda Hospital