Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
研究概览
简要总结
A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.
详细描述
Primary Objective:
To examine the safety and feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Secondary Objectives:
-
To describe changes in liver volume after Y-90 TARE, including:
-
The kinetic growth rate (KGR) of the FLR
-
Degree of hypertrophy 6 weeks after TARE
-
Atrophy of targeted right hemi-liver from TARE date to date of surgery
-
To describe additional interventional procedures needed to induce additional hypertrophy if insufficient hypertrophy from Y-90 TARE
-
To assess the proportion of TARE patients who undergo attempted and complete curative-intent resection of CLM
-
To assess measures of disease control, including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team
- •Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a two-stage hepatectomy strategy, all in the setting of curative-intent resection(s). This evaluation will be documented in the clinical chart
- •Received at least four cycles (or two months) of chemotherapy
- •Willing, able and mentally competent to provide written informed consent
- •Medically and physically operable as determined by the surgeon
排除标准
- •Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable" is defined as having an intended future plan for local therapy (surgery, radiation, or ablation) as determined by the patient's medical oncologist and surgical oncologist
- •Projected sFLR before Y-90 of <20% (starting with sFLR that is unrealistic for improvement to ≥30%)
- •Performance status limitations (Karnofsky <80%, ECOG >1)
- •Portal hypertension and/or cirrhosis
- •Starting total bilirubin >1.3 mg/dL (except if patient has Gilbert's Disease)
- •CEA >200 after 4 cycles of chemotherapy upon restaging visit
- •Clinical progression of disease on imaging and/or tumor marker after 4 cycles of chemotherapy that is clinically judged by surgical oncology and medical oncology to preclude surgical resection
- •Platelet count <100,000/µL
- •Albumin <3.5 g/dl
- •Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy)
- •Pregnant or breast-feeding patient
- •Other medical or clinical contraindications to liver surgery
- •Non-English-speaking participants
研究组 & 干预措施
Yttrium-90
Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows.
干预措施: Yttrium-90 (Y-90) resin microspheres (Drug)
结局指标
主要结局
The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
时间窗: through study completion, an average of 1 year
The evaluation of using the safety of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点