NCT03146377已完成2 期
An Open-label, Single-centre, Single-arm Phase II Study of Triplet Combination of Capecitabine, Oxaliplatin and Irinotecan (Xeloxiri) as Salvage Therapy in Patients With Refractory Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is an open-label, single centre, single-arm phase II study which aims to assess the efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan (Xeloxiri regimen) in treating patients with refractory metastatic colorectal cancer. Clinical data from patients diagnosed with colorectal cancer will be collected and analyzed in this study. The patients' data will be collected and maintained in the Division of medical oncology of the Department of Medicine, Queen Mary Hospital.
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
- •Adults ≥ 18 years of age, male or female.
- •Histopathologically or cytologically confirmed adenocarcinoma.
- •Failed ≥ 2 lines of standard therapy which must include a fluoropyrimidine, oxaliplatin and/or irinotecan, administered either as monotherapy or doublets.
- •ECOG performance status 0 to
- •Adequate bone marrow reserve.
- •Absolute neutrophil count > 1 × 109/L.
- •Total bilirubin < 3 × the upper limit of the normal range.
- •Life expectancy ≥ 12 weeks.
- •Signed written informed consent form.
排除标准
- •Prior malignant disease other than colorectal cancer within 5 years of study entry.
- •Patients suitable for surgical or locoregional therapies.
- •Patients unable to swallow oral medications.
- •Any evidence of brain metastasis (unless the patient is >6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
- •Active clinically serious infections (> grade 2 NCI / CTC Adverse Event version 3.0).
- •History of allergy to platinum compounds.
- •Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
- •Patients who have severe bone marrow failure.
- •Patients undergoing renal dialysis.
- •History of HIV infection.
- •Seizure disorder requiring medication (such as steroids or anti-epileptics).
- •Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
研究组 & 干预措施
Xeloxiri
Experimental
干预措施: Capecitabine (Drug)
Xeloxiri
Experimental
干预措施: Oxaliplatin (Drug)
Xeloxiri
Experimental
干预措施: Irinotecan (Drug)
结局指标
主要结局
Objective response rate
时间窗: Change from baseline in size approximately every 8 weeks (4 cycles), up to approximately 12 months
次要结局
- Progression-free survival(From date of start until the date of first documented progression or death from disease-related causes or last follow-up, whichever came first, assessed up to 18 months)
- Overall survival(From date of start until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months)
研究者
Dr. YAU Chung Cheung Thomas
Clinical Assistant Professor
The University of Hong Kong
研究点 (1)
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