NCT07764497招募中2 期
A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy in Patients With Inoperable Hepatic Metastasis From Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of participants that undergo liver resection following treatment with FUDR
研究概览
简要总结
The goal of this clinical trial is to assess how many patients with initially inoperable colorectal liver metastasis are able to have a liver surgery after treatment with hepatic artery infusion chemotherapy and standard of care systemic chemotherapy.
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
- •History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Patients with resectable or ablatable lung metastasis are eligible.
- •Physically able to tolerate major partial hepatectomy.
- •The primary tumor may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding. If present, the primary tumor will be resected at the time of pump placement.
- •Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration. (MRI angiogram with contrast of the abdomen may be substituted for CT of the abdomen).
- •The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist. In the event that two hepatobiliary surgeons cannot agree, a third surgeon will be consulted. Continued discrepancy will result in the patient's case being presented at weekly hepatobiliary conference for consensus opinion. Inoperable metastases are defined as: requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial/portal inflow, venous outflow and biliary drainage. * A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments.
- •Patient's liver metastases must comprise <70% of the liver parenchyma.
- •Female patients of child-bearing age must undergo a pregnancy test and have a negative result.
- •A patient must have had prior chemotherapy.
- •Within 14 days of registration: o WBC >3X10E9/L; ANC ≥ 1.5X10E9/L; Platelet count >100X10E9/L; INR < 1.5; HGB ≥ 90 g/L; Estimated creatinine clearance ≥30 ml/min (using Cockcroft and Gault formula); Total serum bilirubin <25.6 umol/L.
- •Age ≥ 18 years.
- •Signed informed consent.
- •Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Patients with limited/responding lung metastases on Physician's discretion.
排除标准
- •Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration).
- •Patient may not have received prior treatment with FUDR.
- •Active infection, ascites, hepatic encephalopathy.
- •Active concurrent malignancies, except a patient's potentially resectable colorectal primary.
- •Extrahepatic metastases except for resectable or ablatable lung metastasis.
- •Patient must not have obstruction of GI or GU tract.
- •Female patients who are pregnant or lactating.
- •Patients may not be receiving any other investigational agents.
- •Patients with history of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded (history of stroke or transient ischemic attack within 6 months prior to Day 1).
- •Serious or non-healing active wound, ulcer, or bone fracture.
- •Chronic daily treatment with aspirin (> 325 mg/d) or nonsteroidal anti- inflammatory medications known to inhibit the platelet function.
- •Presence of bleeding diathesis or coagulopathy.
- •History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure of > 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e. atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or peripheral vascular disease (Grade II or greater).
研究组 & 干预措施
Hepatic arterial infusion pump therapy
Experimental
Hepatic arterial infusion pump therapy with floxuridine (FUDR) and dexamethasone will be administered on Day 1 of each cycle. The pump will be emptied and filled with normal saline on Day 15. Standard of care systemic chemotherapy will be administered on Day 1 and Day 15 as per the treating medical oncologist.
干预措施: Floxuridine (FUDR) (Drug)
结局指标
主要结局
Proportion of participants that undergo liver resection following treatment with FUDR
时间窗: From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
To assess the rate of conversion to liver resection in patients with initially inoperable hepatic-metastases due to colorectal cancer after treatment with hepatic artery infusion pump therapy and standard of care systemic therapy.
次要结局
- Time to disease progression in all participants(From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.)
- Time prior to disease progression in all participants(From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.)
- Time to intrahepatic disease progression in all participants(From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.)
- Time to death in all participants(From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.)
- Number of participants with complete response, partial response, progressive disease, or stable disease as per RECIST Version 1.1(From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy.)
- Number of participants with grade 3 or higher adverse events as per CTCAE Version 4.03(From time of consent to approximately 42 days from last treatment with hepatic artery infusion pump therapy)
研究者
研究点 (1)
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