Combination treatment for advanced colorectal cancer using radiofrequency and chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the combined effects of amplitude modulated radiofrequency electromagnetic field treatment with TAS-102 (Lonsurf) and Bevacizumab in patients suffering from refractory metastatic colorectal cancer, particularly those with liver metastasis. Conducted at Charité Universitätsmedizin Berlin, the trial aims to assess the feasibility and safety of this novel treatment approach, which has not been previously studied in this specific combination. Participants will be monitored for treatment efficacy and safety, with results compared to data from similar patient populations in prospective trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  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:

* Significant extrahepatic metastasis
* 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)

Where it's running

• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Pirus Ghadjar, Prof. Dr.
• Email: pirus.ghadjar@charite.de
• Phone: +49 30 450 527318

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.