NCT01993472终止2 期
Andrographolides With or Without Capecitabine for Elderly Patients With Locally Advanced or Recurrent or Metastasis Inoperable Colorectal Cancer: a Randomized, Open-label Trial.
Gu Yanhong1 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of Andrographolides combined with Capecitabine in treatment of elderly patients with locally advanced or recurrent or metastasis inoperable colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum
- •Locally advanced or recurrent or metastasis inoperable disease
- •At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines. Lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization.
- •Man or woman ≥ 65 years of age
- •Hematological function, as follow: (≤ 10 days prior to randomization)
- •Absolute neutrophil count (ANC) ≥ 1.5×109/L
- •Platelet count ≥ 75×109/L
- •Hemoglobin ≥ 8.0 g/dL
- •Renal function, as follows: (≤ 10 days prior to randomization)
- •Creatinine≤ 1.5×ULN
- •Hepatic function, as follow: (≤ 10 days prior to randomization)
- •Aspartate aminotransferase (AST) ≤ 3×ULN(if liver metastases≤ 5×ULN )
- •Alanine aminotransferase (ALT) ≤ 3×ULN(if liver metastases≤ 5×ULN )
- •Total bilirubin≤ 1.5×ULN
- •Subject or subject's legally acceptable representative has provided informed consent
排除标准
- •Symptomatic brain metastases requiring treatment
- •History of other malignancy, except:
- •Malignancy treated with curative intent and with no known active disease present for ≥ 5 years prior to randomization and felt to be at low risk for recurrence by the treating physician
- •Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicity
- •Radiotherapy≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)≤ 6 months prior to randomization
- •History of interstitial lung disease(ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest CT or MRI
- •History of any medical or psychiatric condition or labortory abnomality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results
- •Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤ 30 days before randomization. If on anticoagulation, subject must be on stable therapeutic dose prior to rangdomization.
- •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements
研究组 & 干预措施
Andrographolides with Capecitabine
Experimental
Capecitabine1250mg/m2 , bid，d1-14，q3w, Andrographolides 500mg，qd，d1-14，q3w;
干预措施: Andrographolides (Drug)
Andrographolides with Capecitabine
Experimental
Capecitabine1250mg/m2 , bid，d1-14，q3w, Andrographolides 500mg，qd，d1-14，q3w;
干预措施: Capecitabine (Drug)
Capecitabin alone
Active Comparator
Capecitabine1250mg/m2 , bid，d1-14，q3w,
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: From date of randomization until the date of first documented progression，assessed up to 100 months
次要结局
- Quality of Life(From date of randomization until the date of death from any cause，assessed up to 100 months)
- overall survival(From date of randomization until the date of death from any cause，assessed up to 100 months)
- Response Rate(From date of randomization until the date of first documented partial response or complete response, assessed up to 100 months)
研究者
Gu Yanhong
Director
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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