A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To determine the feasibility of 90Y TARE in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.
研究概览
简要总结
The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma (ICC).
详细描述
Gemcitabine and cisplatin chemotherapy is the current standard for the treatment of unresectable intrahepatic cholangiocarcinoma. 90Y TARE combined with the current standard may be an ideal way to improve disease control in the liver as almost all patients die from their disease in the liver. The data from this trial would then be used to move to a phase II trial to determine efficacy to see if a phase III trial would be warranted. In addition, assessment of the molecular classification of intrahepatic cholangiocarcinoma could determine if there is difference in survival with chemotherapy and 90Y TARE. Finally, MRI before and after treatment will be used to determine if utilizing the percent increase of mean ADC correlates with survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Histologic Documentation: Core needle biopsy or surgical specimen that confirms intrahepatic cholangiocarcinoma (ICC). Patients must be determined to be unresectable by a multidisciplinary team that includes a hepatobiliary surgeon.
- •No prior liver radiation therapy or immunotherapy for cholangiocarcinoma.
- •Only one previous single agent chemotherapy for ICC allowed.
- •Patient may have prior liver resection.
- •Age > 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2 (see Appendix E)
- •Child's Pugh score of A (see Appendix F)
- •Life expectancy of greater than 4 months
- •Normal organ and marrow function as outlined in the protocol.
- •Willingness to use effective contraceptive methods during the study. Patient may participate in the female (or female partner of male subject), either is not of childbearing potential (defined as postmenopausal for > 1 year or surgically sterile) or is practicing two forms of contraception. Sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide).
- •Patients with well controlled HIV infection are eligible if their CD4 count is >499/cu mm and viral load is < 50 copies/ml.
- •Pre-certification for the 90Y TARE should be performed prior to enrollment on this study.
- •All patients must be informed of the investigational nature of this study and must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have had major surgery within 4 weeks prior to entering the study or those who have not recovered from complications from a surgery more than 4 weeks earlier.
- •Patients may not be receiving any other investigational agents.
- •Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association (NYHA) Criteria
- •Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as defined by Child-Pugh Class B or C
- •Pregnant women are excluded from this study.
研究组 & 干预措施
90Y TARE with Gemcitabine and Cisplatin
90Y TARE will be given on day 3 or 4 of cycle 1 and start at 75% of the dose calculated by the body surface area formula and escalated by 25% per cohort in combination with cisplatin 25 mg/m2 and gemcitabine 300 mg/m2 in cycles 1 and 2.
Once the 90Y TARE has reached the 100% dose level, the gemcitabine dose will increase to 600mg/m2 in dose level 3 and 1000mg/m2 in dose level 4. The cisplatin dose will remain at 25/mg/m2.
For all dose levels, from cycle 3 to cycle 8, the cisplatin dose will be 25mg/m2 and the gemcitabine dose will be 1000mg/m2.
干预措施: SIR-Spheres microspheres (Yttrium-90 Microspheres) (Device)
90Y TARE with Gemcitabine and Cisplatin
90Y TARE will be given on day 3 or 4 of cycle 1 and start at 75% of the dose calculated by the body surface area formula and escalated by 25% per cohort in combination with cisplatin 25 mg/m2 and gemcitabine 300 mg/m2 in cycles 1 and 2.
Once the 90Y TARE has reached the 100% dose level, the gemcitabine dose will increase to 600mg/m2 in dose level 3 and 1000mg/m2 in dose level 4. The cisplatin dose will remain at 25/mg/m2.
For all dose levels, from cycle 3 to cycle 8, the cisplatin dose will be 25mg/m2 and the gemcitabine dose will be 1000mg/m2.
干预措施: Gemcitabine (Drug)
90Y TARE with Gemcitabine and Cisplatin
90Y TARE will be given on day 3 or 4 of cycle 1 and start at 75% of the dose calculated by the body surface area formula and escalated by 25% per cohort in combination with cisplatin 25 mg/m2 and gemcitabine 300 mg/m2 in cycles 1 and 2.
Once the 90Y TARE has reached the 100% dose level, the gemcitabine dose will increase to 600mg/m2 in dose level 3 and 1000mg/m2 in dose level 4. The cisplatin dose will remain at 25/mg/m2.
For all dose levels, from cycle 3 to cycle 8, the cisplatin dose will be 25mg/m2 and the gemcitabine dose will be 1000mg/m2.
干预措施: Cisplatin (Drug)
结局指标
主要结局
To determine the feasibility of 90Y TARE in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.
时间窗: Up to 2 years
A continual reassessment method (CRM) design will be used to confirm the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in regards to 90Y TARE.
次要结局
未报告次要终点