NCT03638141已完成2 期
The Effect of CTLA-4/PD-L1 Blockade Following Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC Using Durvalumab (MEDI4736) and Tremelimumab
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Age ≥18 years.
- •Patients with diagnosis of HCC either by high-resolution imaging (triple-phase CT or MRI) and/or by tumor biopsy.
- •Patient is not on systemic treatment for diagnosis of HCC
- •HCC meeting Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage), with measurable lesions on CT or MRI and without extrahepatic spread
- •Have measurable disease
- •Have disease that responds to DEB-TACE
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Child-Pugh Score of A or early B (score ≤8) without clinically significant ascites
- •Body weight >30 kg
- •Patients must have adequate organ function defined by study-specified laboratory tests.
- •Evidence of post-menopausal status or negative pregnancy test
- •Willing and able to comply with study procedures
- •Willing to undergo a liver biopsy
排除标准
- •Anyone involved with the planning and/or conduct of the study.
- •Has participated in another investigational study during the last 6 months.
- •Any concurrent anticancer therapy or received therapy ≤30 days prior to study.
- •Major surgical procedure at the time of study enrollment or within 28 days prior to the first dose of study drug.
- •Have a vascular invasion or extrahepatic tumor.
- •Main portal vein thrombosis present on imaging.
- •Uncontrolled hepatic encephalopathy at time of enrollment. - Ascites within 6 weeks prior to study treatment.
- •Any contraindications for embolization.
- •Has an active infection such as Tuberculosis, HIV, hepatitis B or C.
- •History of another primary malignancy or myeloproliferative disorder.
- •History of leptomeningeal carcinomatosis.
- •History of active primary immunodeficiency.
- •Any unresolved toxicities from previous anticancer therapy.
- •Active or prior documented GI bleeding due to ulcer or esophageal varices bleeding within 6 months.
- •History or current use of immunosuppressive medications within 14 days prior to study medications.
- •Major surgical procedure within 28 days prior to the first dose of IP.
- •Has an active known or suspected autoimmune disease.
- •Patients with hypothyroidism.
- •Any active skin conditions.
- •History of allogenic organ transplantation.
- •Significant heart disease.
- •Patients weighing < 30 kg.
- •Patients with celiac disease not controlled by diet alone.
- •Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Have received a live vaccine within 30 days prior to study drug.
- •Woman who are pregnant or breastfeeding.
- •Known allergy or hypersensitivity to the study drug.
- •Have received durvalumab, tremelimumab, anti-PD-1, anti-PD-L1 or anti-CTLA-4 in a prior study.
- •Unwilling or unable to follow the study schedule for any reason.
研究组 & 干预措施
Durvalumab in combination with Tremelimumab
Experimental
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 doses/cycles.
干预措施: Durvalumab (Drug)
Durvalumab in combination with Tremelimumab
Experimental
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 doses/cycles.
干预措施: Tremelimumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 26 months
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on mRECIST criteria. CR = Disappearance of any intratumoral arterial enhancement in all target lesions, PR = At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
次要结局
- Drug-related Toxicity(up to 16 months)
- Progression Free Survival (PFS)(up to 58 months)
- Overall Survival (OS)(up to 58 months)
研究者
研究点 (1)
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