EUCTR2022-003561-38-FR进行中（未招募）1 期
Durvalumab/Tremelimumab in neoadjuvant and adjuvant setting in patients with HCC treated by electroporation ablation in curative intent: French multicenter phase 2 therapeutic DUMELEP trial (DUMELEP) - DUMELEP
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •- Male or female patients = 18 years of age
- •- Histological or radilogical diagnosis of HCC
- •- Patients with newly diagnosed or recurrent HCC (following a previous curative procedure performed at least 6 months before inclusion) eligible for IRE as assessed by multidisciplinary board corresponding to BCLC A stage:
- •x Uninodular HCC = 2 cm and = 5 cm, no macroscopic vascular invasion
- •x Multinodular maximum 3 nodules = 3 cm, Body weight >30 kg
- •x At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC
- •x Liver function status Child-Pugh Class A
- •- Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
- •x Total bilirubin = 2 mg/dL
- •x Serum creatinine = 1.5 x ULN
- •x Lipase = 2 x ULN
- •x Prothrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 1.5
- •x Glomerular Filtration Rate (GFR) = 30 mL/min/1.73 m2
- •- Life expectancy = 3 months
- •- Women of childbearing potential (WOCBP) need to accept one effective method of contraception until 3 months after the last infusion of durvalumab and avoid pregnancy
- •- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or180 days after the last dose of durvalumab and tremelimumab combination therapy.
- •- Patients affiliated to a Social Security System
- •- Written informed consent signed
- •- Haemoglobin =9.0 g/dL
- •- Absolute neutrophil count (ANC =1.0 × 109 /L)
- •- Platelet count =75 × 109/L
- •- 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 hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.)
- •- AST (SGOT) and ALT (SGPT) =5x ULN
- •- Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- •Creatinine CL (mL/min) = Weight (kg) x (140 – Age)
- •72 x serum creatinine (mg/dL)
- •Creatinine CL (mL/min) = Weight (kg) x (140 – Age) x 0.85
- •72 x serum creatinine (mg/dL)
- •- 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.
- •- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to inclusion
- •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 30
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Not enough room: see protocol
研究者
相似试验
进行中（未招募）
2 期
Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by by Percutaneous Ablation ProcedureNCT06045975Assistance Publique - Hôpitaux de Paris30
已完成
2 期
A Phase II Study of Durvalumab and Tremelimumab in combination with Neoadjuvant Carboplatin and Paclitaxel in newly diagnosed women with advanced high grade Serous Ovarian, Fallopian Tube and Peritoneal Cancers iPRIME”.Fallopian tube cancerPeritoneal cancerCancer - Ovarian and primary peritonealOvarian cancerACTRN12618000109202Australia New Zealand Gynaecological Oncology Group (ANZGOG)75
已完成
2 期
Neoadjuvant and Adjuvant Durvalumab in Combination With Neoadjuvant Chemotherapy in Patients With Operable Urothelial Cancer.Urothelial CancerNCT03406650Swiss Group for Clinical Cancer Research61
进行中（未招募）
1 期
Treatment to modulate the activity of the immune system in combination with chemotherapy treatment in patients with operable urothelial cancerEUCTR2017-003565-10-DESwiss Group for Clinical Cancer Research61
进行中（未招募）
2 期
Durvalumab and Tremelimumab +/- Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)ung Cancer MetastaticLung Cancer MetastaticCancer - Lung - Non small cellACTRN12617001468314HMRC Clinical Trials Centre53