EUCTR2018-002936-26-DE进行中（未招募）1 期
Efficacy and safety of Trifluridine/Tipiracil in combination with Irinotecan as a second line therapy in patients with Cholangiocarcinoma - TRITICC
Heinrich-Heine-University Düsseldorf0 个研究点目标入组 28 人开始时间: 2018年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) prior to performing any protocol-related procedures, including screening evaluations
- •2.Age = 18 years at time of study entry
- •3.Histologically or cytologically confirmed, non-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma
- •4.Measurable or assessable disease according to RECIST 1.1
- •5.Documented disease progression after prior gemcitabine or gemcitabine containing therapy. Examples of permitted therapies include, but are not limited to: a) Single agent gemcitabine); b) Any gemcitabine-based regimen, with or without maintenance gemcitabine
- •6.ECOG performance status 0-1
- •7.Ability to take medications orally
- •8.Adequate blood count, liver-enzymes, and renal function:
- •- ANC > 1,500 cells/µL without the use of hematopoietic growth factors; and Platelet count = 100 x 109/L (>100,000 per mm3) and Hemoglobin > 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)
- •- Serum total bilirubin = 1.5x upper normal limit (ULN) (biliary drainage is allowed for biliary obstruction; elevated bilirubin should be caused by obstruction not impaired liver function as assessed by albumin and INR values):
- •- Albumin levels = 3.0 g/dL
- •- Patients not receiving therapeutic anticoagulation must have an INR< 1.5 ULN and PTT < 1.5 ULN within 7 days prior to inclusion. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion.
- •- AST (SGOT) and ALT (SGPT) = 5 x institutional upper limit of normal
- •- Serum Creatinine = 1.5 x ULN and a calculated glomerular filtration rate = 30 mL per minute Adequate renal and bone marrow function
- •9.In case of liver cirrhosis: Child-Pugh A
- •10.Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1.Age < 18 years
- •2.CNS metastases
- •3.Active, uncontrolled infection
- •4.Additional malignancy within the past 2 years (except adequately treated in-situ carcinoma of the cervix or non-melanoma skin cancer)
- •5.Clinically significant gastrointestinal disorders including bleeding, inflammation, occlusion, or diarrhea > grade 1
- •6.Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- •7.Known hypersensitivity to Trifluridine/Tipiracil or CPT-11 or their components
- •8.Medication that is known to interfere with any of the agents applied in the trial
- •9.Pregnancy or lactating female
- •10.Prior partial or total gastrectomy
- •11.Previous radio- or radiochemotherapy, previous transarterial chemoembolisation (TACE), radiofrequencyablation (RFA) or selective intraarterial radiotherapy (SIRT) within 3 months prior to inclusion (except radiation for bone metastases)
- •12.Patients who might be dependent on the sponsor, site or the investigator
- •13.Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
- •14.Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
- •15. Use of other investigational treatment within 5 half-lives of
- •enrollment is prohibited.
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