EUCTR2017-003323-30-GB进行中（未招募）1 期
Open-label first line, single-arm phase II study of CisGem combined with pembrolizumab in patients with advanced or metastatic biliary tract cancer - Pembrolizumab in biliary tract cancer
European Organisation for the Research and Treatment of Cancer (EORTC)0 个研究点目标入组 50 人开始时间: 2019年4月26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
- 50
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
- •* Histopathological diagnosis of BTC (intra- or extra-hepatic CCA) or GBC
- •* Non-resectable or recurrent/metastatic BTC
- •* Availability of archival FFPE (formalin-fixed, paraffin-embedded) tumor tissue for biobanking or possibility to collect tumor biopsy sample at study entry either from primary tumor or any accessible metastatic site
- •* Possibility to collect blood samples at baseline and during treatment for translational research project
- •* ECOG performance status 0, 1
- •* Age = 18 with estimated life expectancy >3 months
- •* Adequate hematological, liver, renal, cardiac, biliary function:
- •* Adequate coagulation function
- •* Patient is not currently participating and receiving study therapy or has not participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to enrollment
- •* Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment.
- •* Before patient enrollment, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* Patients with ascites grade 2 (moderate) or higher
- •* Child Pugh B or C hepatic impairment in patients with cirrhosis
- •* Incomplete recovery from previous surgery or unresolved biliary tract obstruction
- •* Active infection requiring therapy. Antibiotic treatment should have been completed 5 days before treatmetn start
- •* Patients who are candidates for curative surgery
- •* Prior systemic chemotherapy for locally advanced or metastatic disease
- •* Prior adjuvant chemotherapy is allowed if the last treatment was completed at least 6 months before trial entry and if neither gemcitabine nor cisplatin were given.
- •* Also, the following treatment modalities are allowed within the rules described below (provided there has been a full recovery):
- •- Surgery: patients may have undergone a non-curative operation (i.e. R2 resection [with macroscopic residual disease] or palliative bypass surgery only). Patients who have previously undergone curative surgery, must have evidence of non-resectable and measurable disease relapse requiring systemic chemotherapy prior to study entry.
- •- Radiotherapy: patients may have received prior radiotherapy (with or without radiosensitising low-dose chemotherapy) for localised disease. However, there must be clear evidence of disease progression post-treatment prior to inclusion in this study.
- •- Photodynamic therapy (PDT) for localized disease only with no evidence of metastatic disease - patients may have received prior PDT, provided the patient has fully recovered and at least 28 days have elapsed since the PDT and there is clear evidence of disease progression at the local site or disease or at a new metastatic site.
- •- PDT for localised disease to relieve biliary obstruction in the presence of metastatic disease
- •- Other previous localised treatments targeting intrahepatic lesions such as selective internal radiation therapy (SIRT) , transarterial chemoembolisation (TACE) and radiofrequency ablation are allowed, provided the patient has fully recovered from the treatment before participating in the study
- •* Active autoimmune disease that has required systemic treatment in past 2 years
- •* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- •* History of or current interstitial lung disease
- •* Diagnosis of immunodeficiency, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- •* Previous allogeneic tissue/solid organ transplant
- •* Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C
- •* Patients with hyperthyroidism or hypothyroidism unless stable on hormone replacement
- •* History of another malignancy or a concurrent malignancy. Exceptions include patients who have been disease-free for 5 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.
- •* Prior treatment with any anti-CTLA4 monoclonal antibody or anti-PD-1, or PD-L1 or PD-L2 agent.
研究者
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