EUCTR2014-001163-12-DK进行中（未招募）1 期
A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) with or without T-ChOSTM as adjuvant therapy in patients with surgically resected pancreatic cancer
Herlev University Hospital, Oncology Dept.0 个研究点目标入组 180 人开始时间: 2016年4月14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
- 180
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.Signed informed consent
- •2.Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded
- •3.Subject should be able to start treatment no later than 12 weeks postsurgery
- •4.Male or non-pregnant, non-lactating females who are =18 years of age at the time of signing the informed consent form (ICF)
- •5.ECOG/WHO Performance Status (PS) 0-1
- •6.Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
- •Agree to the use of two physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3months following the last dose of IP
- •Has negative serum pregnancy test (ß-hCG) result at screening
- •7.Male subjects:
- •Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy
- •8.Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted
- •9.Be able to adhere to the study visit schedule and other protocol requirements
- •10.Acceptable hematology parameters defined as:
- •Absolute neutrophil count (ANC) = 1.5 x 10?/L
- •Platelet count = 100 x 10?/L
- •Haemoglobin = 5.6 mmol/L
- •11.Acceptable liver function defined as:
- •Serum bilirubin < 1.5 x upper limit of normal (ULN)
- •ASAT/ALAT < 2.5 x ULN
- •12.Acceptable renal function with a creatinine clearance = 50 mL/min/ (e.g., using the Cockroft-Gault formula)
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1.Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
- •2.Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
- •3.Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score = 6, PSA < 0.5 ng/ml), or any other tumor with a DSF survival of = 5 years
- •4.History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
- •Active infection requiring antibiotics within 2 weeks before the study inclusion
- •Concurrent congestive heart failure NYHA class III - IV
- •Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
- •History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- •Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- •5.Known or suspected allergy to the investigational agents or any agents given in association with this trial
- •6.Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
- •7.Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
- •8.Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •9.Any condition that confounds the ability to interpret data from the study
- •10.Unwillingness or inability to comply with study procedures
- •11.Current use of anticoagulation therapy such as heparins both unfractionated and low molecular weighted
研究者
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