NCT05991102招募中不适用
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with liver dominant refractory metastatic colorectal cancer
详细描述
Charité Universitätsmedizin Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is only data available regarding the low toxicity profile of radiofrequency electromagnetic field treatment for various regions of the body including the abdomen there is no data available on the combined effect of TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment. 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.
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
- •Written informed consent prior to any study procedure
- •18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Histologically confirmed colorectal cancer
- •Liver metastasis
- •Patients received at least two prior regimens of standard chemotherapies and the patient is refractory to or failing these therapies or is unsuitable for the treatment.Standard chemotherapy includes fluoropyrimidine, oxaliplatin, irinotecan,bevacizumab and for patients with KRAS wild-type tumors at least one anti-EGFR monoclonal antibody of cetuximab/panitumumab. Patients with BRAF mutant tumors: BRAF inhibitor, MSI-H patients: Checkpoint-inhibition
- •Knowledge of KRAS status (i.e. wild-type or mutant)
- •Adequate bone-marrow, liver and renal function:
- •Hemoglobin value of ≥9.0 g/dL.
- •Absolute neutrophil count of ≥1,500/mm3
- •Platelet count ≥100,000/mm3 (IU: ≥100 × 109/L).
- •Total serum bilirubin of ≤1.5 mg/dL
- •Aspartate aminotransferase and alanine aminotransferase
- •≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying Liver metastasis, AST and ALT ≤5 × ULN.
- •Serum creatinine of ≤1.5 mg/dL.
- •Patient is able to take medications orally
- •Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible
排除标准
- •Significant extrahepatic metastasis
- •Previous treatment with TAS 102
- •Serious illness other than colorectal cancer or serious medical condition:
- •Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
- •Known brain metastasis or leptomeningeal metastasis.
- •Active infection (ie, body temperature ≥38°C due to infection).
- •Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks
- •Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder
- •Uncontrolled diabetes.
- •Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA III/IV)
- •Gastrointestinal hemorrhage.
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
- •Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
- •Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
- •Radiofrequency treatment technically not possible (e.g. larger metal implants)
- •Cardiac pacemakers/ICD
- •Patient not able for supine positioning (e.g. due to pain)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Through study completion, an average of 3 months
(≥ partial response)
次要结局
- OS(Through study completion, an average of 1 year)
- Acute and late toxicity(During 3 years of trial conduction)
- PFS(Through study completion, an average of 6 months)
- Anxiety and depression(During 3 years of trial conduction)
- QoL(During 3 years of trial conduction)
研究者
Pirus Ghadjar
Prof. Dr.
Charite University, Berlin, Germany
研究点 (2)
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