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

NCT05991102 | Recruiting

• 1 other identifier: Live-RF
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractory Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  (≥ partial response)

  Through study completion, an average of 3 months

Secondary Outcomes (6)

• PFS

  Through study completion, an average of 6 months

• OS

  Through study completion, an average of 1 year

• QoL

  During 3 years of trial conduction

• QoL

  During 3 years of trial conduction

• Anxiety and depression

  During 3 years of trial conduction

Study Arms (1)

TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment

EXPERIMENTAL

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.

Device: Radiofrequency electromagnetic field treatment

Interventions

Radiofrequency electromagnetic field treatment DEVICE

Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Also known as: mEHT, capacitive hyperthermia, electrohyperthermia

TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Pirus Ghadjar, Prof. Dr.

CONTACT

+49 30 450 527318; pirus.ghadjar@charite.de

Marcus Beck, Dr.

CONTACT

+49 30 450 527318; marcus.beck@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 14, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

DE (1)