EUCTR2016-003306-13-GB进行中（未招募）1 期
CCR 4557: Peri-operative Immuno-Chemotherapy in Operable oesophageal aNd gastrIc Cancer (ICONIC Trial) - ICONIC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 53
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
入选标准
- •i.Histologically confirmed gastric, gastro-oesophageal junction or oesophageal adenocarcinoma (referred to as gastro-oesophageal adenocarcinoma (GOA) in this protocol).
- •ii.Oesophageal and gastric tumours should be TNM7 stage T1-3 and N0-N2, with no evidence of distant metastases (M0) where the MDT believes that an R0 resection can be achieved at the outset. T4 tumours will be excluded due to the variable need to prolong pre-operative chemotherapy or chemo-radiotherapy as part of locally advanced protocol to reduce margin involvement and improve resectability.
- •iii.Absence of distant metastases on CT scan and PET scan and staging laparoscopy (where indicated) prior to study entry
- •iv.No prior therapy for GOA
- •v.Adequate cardio-pulmonary reserve as assessed by: Supervised Incremental Shuttle Walk threshold > 350 metres, or formal CPET testing with an anaerobic threshold =9 mls/min/kg.
- •vi.Adequate bone marrow function:
- •Absolute neutrophil count (ANC) >1.5x10-9/L
- •White blood count >3x10-9/L
- •Platelets =100x10-9/L
- •Haemoglobin (Hb) >9g/dl (can be post-transfusion)
- •viii.Adequate renal function: glomerular filtration rate (GFR) =30ml/min calculated (as per local practice) or measured. If the calculated GFR is <60ml/min then a measured GFR is required. The measured GFR should always take precedence over the calculated GFR
- •ix.Adequate liver function
- •Serum bilirubin =1.5x ULN
- •ALT/AST =2.5x ULN
- •x.Adequate coagulation profile
- •International Normalised Ratio (INR) < 1.5
- •Activated Prothrombin Time (APTT) < 1.5xULN
- •xi.Patients on oral anticoagulation are advised to change to low molecular weight heparin prior to study entry, to be eligible
- •xii.ECOG performance status 0 or 1
- •xiii.BMI =35
- •xiv.Patient is fit to undergo all protocol investigations and receive all protocol treatment based on the assessment in the surgical and oncology clinics
- •xv.Male/female patients aged =18 years
- •xvi.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
- •xvii.Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients are not eligible for the trial if any of the exclusion criteria below are met:
- •i.Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of Folinic acid, Oxaliplatin, or 5FU
- •ii.Known severe hypersensitivity reactions to monoclonal antibodies (Grade = 3 NCI CTCAE v 4.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more features of partially controlled asthma)
- •iii.Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •iv.Patients who have received chemotherapy, radiotherapy or immunotherapy for a previous malignancy
- •v.Any previous malignancy, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- •vi.Patients recommended to have radiotherapy as part of routine management for their GOA are ineligible
- •vii.Any immunodeficiency disorder
- •viii.Any active, known or suspected autoimmune disease that might deteriorate when receiving immunostimulatory agent, with the following exceptions:
- •Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- •Patients requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses =10mg (or equivalent) of prednisolone per day
- •Administration of steroids through a route known to result in minimal systemic exposure (topical, intranasal intra-ocular, or inhalation) are acceptable
- •ix.Prior organ transplantation, including allogeneic stem-cell transplantation
- •x.History of inflammatory bowel disease
- •xi.Patients with a history of interstitial lung disease or radiological evidence of pulmonary fibrosis
- •xii.Cerebrovascular disease (including transient ischaemic attacks (TIA) and strokes) within the previous year
- •xiii.Cardiovascular diseases as follows:
- •Myocardial infarction within the previous year
- •Serious cardiac arrhythmia requiring medication (for example,
- •ventricular tachycardia, supraventricular tachycardia or atrial fibrillation with a resting heart rate > 110bpm)
- •xiv.Current signs or symptoms of any other severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, respiratory or cardiac disease other than directly related to gastro-oesophageal adenocarcinoma, which in the opinion of the investigator, might impair the subject’s tolerance of trial treatment or procedures.
- •xv.Major surgery, major trauma or open biopsy within 28 days prior to registration (not including staging laparoscopy)
- •xvi.Evidence of bleeding diathesis or coagulopathy
- •xvii.Active non-healing wound, ulcer or bone fracture requiring therapy
- •xviii.Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis A or C virus, acute or chronic active hepatitis B infection
- •xix.Known peripheral neuropathy > grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
- •xx.Use of live attenuated vaccine within 28 days of
研究者
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