Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.
详细描述
It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy.
S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •More than 3 months expected life span
- •Measurable lesion by RECIST criteria version 1.1
- •Palliative chemotherapy naive
- •Adequate organ functions
- •Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
排除标准
- •Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer.
- •Participants who had received radiation therapy for target lesions 4 weeks before study enrollment
- •Participants who had received major surgery 4 weeks before study enrollment
- •Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding
- •Participants with central nervous system(CNS) metastases
- •Participants with peripheral sensory neuropathies with impaired functional activities
- •Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.
研究组 & 干预措施
Oxaliplatin, Irinotecan, S-1(OIS)
intervention with triple combination chemotherapy with oxaliplatin, irinotecan, and S-1 Treatment will be delivered as a 2-week cycle.
- Oxaliplatin 65 mg/m2 iv on day 1
- Irinotecan 135 mg/m2 iv on day 1
- S-1 80 mg/m2/day on day 1-7
干预措施: Oxaliplatin, Irinotecan, S-1 (Drug)
结局指标
主要结局
overall response rate
时间窗: 1.5 year
Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
次要结局
- progression free survival(1.5 year)
- toxicity profiles - the number of participants and grade of intensity of treatment related adverse events(1.5 year)
- overall survival(1.5 year)