ACTRN12617001268336招募中1 期
Phase Ib/II Study of Intra-Arterial Liver Isolation Chemotherapy in Patients with Hepatic Metastases from Colorectal Cancer
AllVascular Pty Ltd0 个研究点目标入组 95 人开始时间: 2017年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 95
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Males or females, aged 18 years or older, with hepatic metastases from histologically proven adenocarcinoma of the colon/rectum;
- •2. Limited extrahepatic metastases in the lung or lymph nodes;
- •3. Confirmed non-progressive disease in the liver, per RECIST v1.1, halfway into the first-line systemic chemotherapy regimen after a minimum of 4 cycles of FOLFOX/XELOX ± monoclonal antibodies OR liver-dominant pre-treated or refractory patients;
- •4. Genotype: RAS mutant for first line patients only. All genetic mutations allowable for pre-treated or refractory patients;
- •5. Prior treatment with monoclonal antibody treatment is 'greater than or equal to' 4 weeks before implantation;
- •6. Considered medically fit for repeated general anaesthesia;
- •7. ECOG performance status 0-1;
- •8. Adequate bone marrow function (within 14 days of enrolment):
- •Haemoglobin greater than or equal to 100 g/L;
- •ANC greater than or equal to 1.5 × 10^9/L;
- •Platelet Count greater than or equal to 100 × 10^9/L;
- •9. Adequate renal function (within 14 days of enrolment):
- •Serum Creatinine less than or equal to 1.5 × Upper Limit of Normal;
- •10. Adequate liver function (within 14 days of enrolment):
- •Bilirubin less than or equal to 2.0 × Upper Limit of Normal;
- •AST less than or equal to 5 × Upper Limit of Normal;
- •11. Normal coagulation (within 14 days of enrolment):
- •INR less than or equal to 1.5
- •12. Able to understand the risks and benefits of the study and provide signed, written informed consent to participate;
- •13. Willing and able to comply with all study requirements and assessments;
排除标准
- •1. CT-angiogram confirms unsuitable vascular anatomy;
- •2. No measurable liver disease per RECIST v1.1;
- •3. Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis;
- •4. Allergies to contrast agents;
- •5. Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin;
- •6. Previous allergies associated with 5-FU or oxaliplatin;
- •7. Grade > 2 peripheral neuropathy (CTCAE 5.0)
- •8. Significant co-morbidities;
- •9. Life expectancy less than or equal to 3 months;
研究者
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