Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
NCT ID: NCT05991102
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2023-12-15
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment
Each treatment cycle with TAS-102 will be 28 days in duration.
One treatment cycle consists of the following:
* Days 1: Bevacizumab (5 mg/m2/dose) intravenous.
* Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5.
* Days 6 through 7: Recovery
* Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
* Days 13 through 28: Recovery
* Days 15: Bevacizumab (5 mg/m2/dose) intravenously.
Radiofrequency electromagnetic field treatment using the EHY-2030 device starts within the first week of systemic therapy 2 times weekly (60 min each) with an interval of at least 48h. A modulated electric field with a carrier radiofrequency 13.56 MHz will be generated.
Radiofrequency electromagnetic field treatment
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Interventions
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Radiofrequency electromagnetic field treatment
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Hemoglobin value of ≥9.0 g/dL.
2. Absolute neutrophil count of ≥1,500/mm3
3. Platelet count ≥100,000/mm3 (IU: ≥100 × 109/L).
4. Total serum bilirubin of ≤1.5 mg/dL
5. 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.
6. 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
Exclusion Criteria
* Previous treatment with TAS 102
* Serious illness other than colorectal cancer or serious medical condition:
1. Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
2. Known brain metastasis or leptomeningeal metastasis.
3. Active infection (ie, body temperature ≥38°C due to infection).
4. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks
5. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder
6. Uncontrolled diabetes.
7. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA III/IV)
8. Gastrointestinal hemorrhage.
9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
10. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
11. 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)
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Pirus Ghadjar
Prof. Dr.
Locations
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Charité Universitätsmedizin Berlin
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Yvonne Saewe
Role: primary
Other Identifiers
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Live-RF
Identifier Type: -
Identifier Source: org_study_id