NCT00301379终止不适用
Prospective Registry Study of Neoadjuvant Therapy in Conjunction With Liver Transplantation for Cholangiocarcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Proportion of patients withdrawn due to toxicity and other treatment related events.
研究概览
简要总结
This is an observational study intended to validate results of a previous study done at the Mayo Clinic. Patients are treated with combination chemotherapy and radiation and maintained on oral Xeloda until they can receive liver transplant. A staging laparotomy is performed before chemoradiation in order to identify patients who will most benefit from the treatment and to improve outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosis of cholangiocarcinoma that has been established preoperatively by at least one of the following criteria:
- •A positive brush cytology or biopsy result obtained at the time of cholangiography;
- •Fluorescence in situ hybridization demonstrating aneuploidy;
- •A serum CA 19-9 value greater than 100 U/mL in the presence of a radiographically characteristic malignant stricture in the absence of cholangitis.
- •Listed for OLT for hilar cholangiocarcinoma
- •Tumor/stricture is above the cystic duct and is unresectable.
- •A suitable candidate for orthotopic liver transplantation as judged by the liver transplant team. All 3 treatment modalities are not needed to confirm eligibility for this registry trial.
- •>/= 18 years of age.
- •Willing and able to provide written informed consent.
排除标准
- 未提供
结局指标
主要结局
Proportion of patients withdrawn due to toxicity and other treatment related events.
时间窗: Completion of treatment for all patients (estimated to be 18 years total)
次要结局
- Proportion of patients who respond to treatment(Completion of treatment for all patients (estimated to be 18 years total))
- Overall survival(Completion of treatment for all patients (estimated to be 18 years total))
- Disease-free survival(Completion of treatment for all patients (estimated to be 18 years total))
研究者
研究点 (1)
Loading locations...
相似试验
Enrolling By Invitation
不适用
Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable ESCCResectable Esophageal Squamous Cell CarcinomaNCT06475196Tang-Du Hospital90
Unknown
1 期
Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck CancerHead and Neck NeoplasmsNCT00982436University of Vermont37
已完成
2 期
Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx CancerOropharynx CancerNCT03838263UNICANCER62
Unknown
2 期
Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical TrialOvarian NeoplasmsNCT00551577University Hospital, Bonn100
招募中
3 期
Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical CancerCervical CancerNCT05173272Sichuan Cancer Hospital and Research Institute286