EUCTR2014-004981-52-DE进行中（未招募）1 期
ab-Paclitaxel (Abraxane®) and Gemcitabine as first line therapy in patients with cholangiocarcinoma ineligible for cisplatin-based chemotherapy – a pilot studyThe NACHO trial (GEMNABCCC-001) - The NACHO trial
niversity Hospital Essen0 个研究点目标入组 10 人开始时间: 2015年12月17日最近更新:
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
- 10
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
- •?signed informed consent before start of specific protocol procedure
- •?age > 18 years
- •?histologically or cytologically documented diagnosis of cholangiocellular carcinoma, bile duct cancer or gall bladder carcinoma
- •?presence of at least one measurable site of disease following RECIST 1.1 criteria
- •?unresecable, metastatic or recurrent disease
- •?ECOG performance 0 or 1
- •?life expectancy of at least 3 months
- •?any contraindication for Cisplatin, i.e. renal impairment (creatinine clearance < 60 ml/min), impaired hearing, increased risk or history for thromboembolic events, intolerance of extensive hydration, left ventricular ejection fraction (LVEF) < 45%
- •?adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
- •?absolute neutrophil count (ANC) = 1500/µl
- •?platelet count = 100,000/µl
- •?total bilirubin < 3 x ULN and sufficient biliary drainage
- •?ALT and AST < 3 x ULN, < 5 x ULN if liver metastasis present
- •?PT-INR/PTT < 1.5 x ULN, patients therapeutically anticoagulated with NMH, heparin or NOACs (dabigatran, rivaroxaban, abixaban) are allowed to participate, patients anticoagulated with phenoprocoumon or warfarin should be switched to NMH, heparin or NOACs
- •?creatinine clearance = 30ml/min and serum creatinine = 2.5 x ULN
- •?confirmed menopause, negative pregnancy test within 7 days of the start of treatment and willingness to use highly effective methods of contraception
- •?willingness and able to comply with the protocol for the duration of the study
- •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 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •?no prior anti-cancer chemotherapy or radiotherapy for metastatic, advanced or recurrent disease; adjuvant/additive chemotherapy or radiotherapy after resection is allowed if therapy free intervall is at least 4 months; concomitant small volume palliative radiotherapy of bone metastases are allowed
- •?investigational drug therapy during or within 4 weeks of study entry
- •?major surgery within 4 weeks of starting therapy within this study
- •?symptomatic brain metastasis
- •?clincially significant cardiovascular disease (incl. Myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
- •?active clinically serious infections (> grade 2 NCI-CTC version 4.0)
- •?history of interstitial lung disease
- •?liver cirrhosis child-pugh score > 8
- •?history of HIV infection or chronic hepatitis B or C
- •?pre-exisiting neuropathy > grade 1 (NCI-CTC version 4.0)
- •?patients with evidence of bleeding diathesis
- •?patients with second primary cancer within 5 years, exept adequately treated basal skin cancer or carcinoma in-situ of the cervix or bladder, or low/intermediate risk prostate cancer (Gleason score = 7) with normal PSA levels
- •?any condition that could jeopardize the safety of the patient and their compliance of the study
- •?breast-feeding patients
- •?substance abuse, medical, psychological or social conditions that may interfere with the participation in the study
研究者
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