RecruitingNot ApplicableNCT05991102

Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer

Sponsor

Charite University, Berlin, Germany

Enrollment

12 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with liver dominant refractory metastatic colorectal cancer

Min Age: 18 Years

Written informed consent prior to any study procedure
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

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)

DEVICERadiofrequency electromagnetic field treatment

Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Charité Universitätsmedizin Berlin

Berlin, Germany

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NCT05991102