EUCTR2018-004758-39-IT进行中（未招募）1 期
A PHASE II STUDY OF CAPECITABINE PLUS CONCOMITANT RADIATION THERAPY FOLLOWED BY DURVALUMAB (MEDI4736) AS PREOPERATIVE TREATMENT IN RECTAL CANCER - PANDORA
AZIENDA UNITÀ SANITARIA LOCALE DELLA ROMAGNA0 个研究点目标入组 60 人开始时间: 2021年6月17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
- 60
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.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and Data Privacy Directive obtained from the patient/legal representative prior to performing any protocol- related procedures, including screening evaluations.
- •2.Age > 18 years at time of study entry.
- •3.Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- •4.Histological diagnosis of adenocarcinoma of rectum.
- •5.Clinical stage 2-3 rectal adenocarcinoma, cT3/4N0/M0 or Tx N1-2/M0, assessed by thorax abdomen pelvis with contrast Computed tomography (CT) scan, pelvi Magnetic resonance imaging (MRI) scan, pancolonscopy.
- •6.Able to swallow oral medication.
- •7.Body weight >30kg.
- •8.Adequate normal organ and marrow function as defined below:
- •Haemoglobin =9.0 g/dL
- •Absolute neutrophil count (ANC) > 1500 per mm3
- •Platelet count >100.000 per mm3
- •Serum bilirubin =1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- •AST (SGOT)/ALT (SGPT) =2.5 x institutional upper limit of normal
- •Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976).
- •9.Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients. Women of childbaring potential or male patients with a female partner of childbearing potential must agree to use at least 1 highly effective method of contraception from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy) as detailed in section 7.1. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •Women <50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post- menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •Women =50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- •10.Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •11.Must have a life expectancy of at least 12 weeks.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Exclusion Criteria:
- •1.Previous treatment for local advanced rectum cancer.
- •2.Concurrent enrolment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- •3.Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
- •4.History of hypersensitivity to fluorouracil.
- •5.Known Dihydropyrimidine dehydrogenase (DPD) deficiency.
- •6.History of another primary malignancy except for:
- •-Malignancy treated with curative intent and with no known active disease =5 years before the first dose of study drug and of low potential risk for recurrence
- •-Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •-Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ
- •7.Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at
- •physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion:
- •-Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- •-Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- •-Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- •8.Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- •9.Major surgical procedure within 28 days prior to the first dose of treatment.
- •10.Uncontrolled intercurrent illness
研究者
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