EUCTR2018-000708-40-FR进行中（未招募）1 期
Association of Radiochemotherapy and Immunotherapy for the treatment of unresectable Oesophageal caNcer: a comparative randomized phase II trial. - ARIO
ICANCER0 个研究点目标入组 120 人开始时间: 2018年10月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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. Histologically proven squamous cell carcinoma or adenocarcinoma of the oesophagus,
- •2. Unresectable disease due to anatomical consideration or medical condition,
- •3. Presence of at least one measurable lesion >10 mm with spiral CT scan,
- •4. Age =18 years old,
- •5. WHO performance status <2 (i.e., 0 or 1),
- •6. Body weight >35 kg,
- •7. Life expectancy of at least 12 weeks ,
- •8. Adequate haematology laboratory data within the 7 days before randomization
- •a. Absolute neutrophils >1.5 x 109/L
- •b. Platelets >100 x 109/L
- •c. Haemoglobin =9 g/dL,
- •9. Adequate Biochemistry laboratory data within the 7 days before randomization
- •a. Total bilirubin =1.5 x upper limit of normal (ULN)
- •b. Transaminases =2.5 x ULN
- •c. Alkaline phosphatases =5 x ULN,
- •d. Measured creatinine clearance (CL) >40 mL/min or calculated creatinine CL >40 mL/min by the Cockcroft-Gault formula,
- •e. Glycaemia =1.5 x ULN
- •f. Cholesterolaemia =7.30 mmol/L,
- •g. Albumin >28 g/L
- •10. Adequate haemostasis laboratory data within 7 days prior to randomization: prothrombin time (PT) within the normal range,
- •11. Women should be post-menopaused or willing to accept the use an effective contraceptive regimen during the treatment period and for at least 6 months after the end of the study. All non-menopausal women should have a negative pregnancy test within 72 h prior to randomization. Men should accept to use an effective contraception during treatment period and at least 3 months after the end of the study.
- •12. Patients must have provided consent for the study by signing and dating a written informed consent form prior to any study specific procedures, sampling, or analyses,
- •13. Patient affiliated to a social security regimen.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Previous treatment with another PD-1, PD-L1 including durvalumab or CTLA-4 inhibitor
- •2. Metastatic disease,
- •3. No prior therapy for pathology investigated including chemotherapy or radiotherapy prior to the study, except anterior out of field radiotherapy, received for treatment of another primary tumor considered in remission,
- •4. Patients should not receive live vaccine 30 days prior to study drug
- •5. Female patients who are pregnant or breastfeeding
- •6. Uncontrolled intercurrent illness including, but not limited to diabetes, hypertension, pulmonary failure, chronic renal or hepatic diseases, active peptic ulcer disease or gastritis, active bleeding, diatheses... (non-exhaustive list),
- •7. Clinically significant cardiac disease or impaired cardiac function, such as:
- •a. Congestive heart failure requiring treatment (New York Heart Association [NYHA] grade =2), left ventricular ejection fraction (LVEF) <50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled arterial hypertension defined by blood pressure >140/100 mmHg at rest (average of 3 consecutive readings),
- •b. History or current evidence of clinically significant cardiac arrhythmias, atrial fibrillation and/or conduction abnormality, e.g. congenital long QT syndrome, high- grade/complete AV-blockage,
- •c. Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting), <3 months prior to screening,
- •d. MeanQT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction.
- •8. Current or prior use of immunosuppressive medication within 28 days before the first administration of durvalumab (exception: systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent are allowed as well as steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) - Topical, inhaled, nasal, and ophthalmic steroids are allowed,
- •9. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
- •a. Patients with vitiligo or alopecia
- •b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stabilised with hormone replacement therapy
- •c. Any chronic skin condition that does not require systemic therapy
- •d. Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- •e. Patients with coeliac disease controlled by diet alone
- •10. Known primary immunodeficiency or active HIV,
- •11. Patient with a dihydropyrimidine dehydrogenase (DPD) deficiency (the test should be done for all patients before 5-FU administration)* ,
- •12. Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive HBS antibody test for hepatitis B or hepatitis C virus ribonucleic acid (HCV antibody),
- •13. History of organ transplantation requiring the use of immunosuppressive medication,
- •14. History of active tuberculosis or latent disease capable of reactivation,
- •15. Current pneumonitis or interstitial lung d
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