Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma
详细描述
Charité University Medicine Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is retrospective data available regarding the assumed effectiveness and low toxicity profile of radiofrequency electromagnetic field treatment for various solid tumors including liver cancer, there is no prospective data available on the combined effect of first-line palliative double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma. The investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population who received double immune checkpoint inhibition alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies
- •Written informed consent prior to any study procedure
- •18 years or older
- •Histologically confirmed HCC
- •HCC not amenable to curative (including resection or ablation) or locoregional (including TACE) therapies
- •No prior systemic therapy for HCC
- •Compensated liver function, as defined by a Child-Pugh score ≤ B7
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Measurable disease by Response Criteria in Solid Tumors (mRECIST and RECIST v1.1) criteria
- •Body weight of > 30 kg
- •Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible
- •If present HBV and HCV managed according to the local institutional practice
排除标准
- •Arterioembolic event including a stroke or myocardial infarction within 3 months prior to randomization Severe / unstable angina, or symptomatic congestive heart failure as defined by NYHA III/IV
- •Cardiac pacemakers / ICD
- •Large metal implants in the treatment area
- •Current evidence of coagulopathy or bleeding diathesis
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Decompensated liver function as defined by Child Pugh ≥ B8
- •Patients on a liver transplantation list
- •Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
- •Uncontrolled autoimmune or inflammatory disorders
- •Patient not able for supine positioning (e.g. due to pain)
- •Significantly altered mental status
- •Pregnancy and breastfeeding
研究组 & 干预措施
Experimental
Routine double immune checkpoint inhibition (HIMALAYA phase III trail, STRIDE-arm) combined with radiofrequency electromagnetic field treatment for 60 minutes twice a week
干预措施: Radiofrequency electromagnetic field treatment (Device)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Every 10-12 weeks until progression or a maximum follow-up of 3 years
Objective response rate
次要结局
- Quality of life (QoL)(During 4 years of trial conduction)
- Acute and late toxicity(During 4 years of trial conduction)
- Progression-free survival (PFS)(During 4 years of trial conduction)
- Time to progression (TTP)(During 4 years of trial conduction)
- Overall survival (OS)(During 4 years of trial conduction)
- Duration of response (DOR)(During 4 years of trial conduction)
研究者
Pirus Ghadjar
Prof. Dr.
Charite University, Berlin, Germany