NCT03079427已完成2 期
Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis
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
- 101
- 试验地点
- 1
- 主要终点
- 2-year disease-free survival
研究概览
简要总结
There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal, adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years and older
- •Histologically documented extrahepatic cholangiocarcinoma (perihilar or distal bile duct tumor)
- •Microscopic or macroscopic surgical resection (ie., R0 or R1 resection)
- •Regional lymph node metastasis according to the American Joint Committee on Cancer (AJCC) 7th edition
- •No distant metastasis
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 1
- •No prior chemotherapy or radiotherapy
- •Serum CA 19-9 < 100 U/mL at the time of enrollment
- •Adequate bone marrow function as defined by platelets ≥ 100 x 109/L and neutrophils ≥ 1.5 x 109/L
- •Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN)
- •Adequate hepatic function with serum total bilirubin < 2 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
- •No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 5 years previously without evidence of relapse Written informed consent to the study
排除标准
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
- •Histologies other than adenocarcinoma such as mixed hepatocellular carcinoma/cholangiocarcinoma, adenosquamous carcinoma or mixed adenocarcinoma/neuroendocrine carcinoma
- •Intrahepatic cholangiocarcinoma or gallbladder cancer
- •Obstruction of gastrointestinal tract
- •Active gastrointestinal bleeding
- •Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
- •Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
- •Female subjects who are pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug. A highly effective method of contraception is defined as having a low failure rate (< 1% per year) when used consistently and correctly.
研究组 & 干预措施
Capecitabine
Active Comparator
Adjuvant Capecitabine
干预措施: Capecitabine (Drug)
Gemcitabine plus cisplatin
Experimental
Adjuvant Gemcitabine plus Cisplatin
干预措施: Gemcitabine plus cisplatin (Drug)
结局指标
主要结局
2-year disease-free survival
时间窗: 2 years
Proportion of patients without disease recurrence after 2 years
次要结局
- Overall survival(4 years)
- Disease-free survival(4 years)
- Toxicities (Adverse events related with chemotherapy)(4 years)
研究者
Baek-Yeol Ryoo
Professor
Asan Medical Center
研究点 (1)
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