Clinical trial · Interventional
Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
NCT06821958CI-TRIAL-00085862recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency electromagnetic field treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Routine double immune checkpoint inhibition (HIMALAYA phase III trail, STRIDE-arm) combined with radiofrequency electromagnetic field treatment for 60 minutes twice a week
- interventionNames
- Device: Radiofrequency electromagnetic field treatment
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Every 10-12 weeks until progression or a maximum follow-up of 3 years
- description
- Objective response rate
Secondary outcomes (7)
- measure
- Acute and late toxicity
- timeFrame
- During 4 years of trial conduction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies * Written informed consent prior to any study procedure * 18 years or older * Histologically confirmed HCC * HCC not amenable to curative (including resection or ablation) or locoregional (including TACE) therapies * No prior systemic therapy for HCC * Compensated liver function, as defined by a Child-Pugh score ≤ B7 * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Measurable disease by Response Criteria in Solid Tumors (mRECIST and RECIST v1.1) criteria * Body weight of \> 30 kg * Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible * If present HBV and HCV managed according to the local institutional practice Exclusion criteria: * Arterioembolic event including a stroke or myocardial infarction within 3 months prior to randomization Severe / unstable angina, or symptomatic congestive heart failure as defined by NYHA III/IV * Cardiac pacemakers / ICD * Large metal implants in the treatment area * Current evidence of coagulopathy or bleeding diathesis * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Decompensated liver function as defined by Child Pugh ≥ B8 * Patients on a liver transplantation list * Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy * Uncontrolled autoimmune or inflammatory disorders * Patient not able for supine positioning (e.g. due to pain) * Significantly altered mental status * Pregnancy and breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.