A Prospective Phase II Study Evaluating Intraoperative Electrochemotherapy of Hepatocellular Carcinoma.
Mihajlo DjokicMaja CemazarMasa BosnjakRok DezmanDavid BadovinacDamijan MiklavčičBor KosMiha StabucBorut StabucRado JansaPeter PopovicLojze M SmidGregor SersaBlaz TrotovsekPublished in: Cancers (2020)
The aim of this clinical study was to investigate the effectiveness and long-term safety of electrochemotherapy as an emerging treatment for HCC in patients not suitable for other treatment options. A prospective phase II clinical study was conducted in patients with primary HCC who were not suitable for other treatment options according to the Barcelona Clinic Liver Cancer classification. A total of 24 patients with 32 tumors were treated by electrochemotherapy. The procedure was effective, feasible, and safe with some procedure-related side effects. The responses of the 32 treated nodules were: 84.4% complete response (CR), 12.5% partial response (PR), and 3.1% stable disease (SD). The treatment was equally effective for nodules located centrally and peripherally. Electrochemotherapy provided a durable response with local tumor control over 50 months of observation in 78.0% of nodules. The patient responses were: 79.2% CR and 16.6% PR. The median progression-free survival was 12 months (range 2.7-50), and the overall survival over 5 years of observation was 72.0%. This prospective phase II clinical study showed that electrochemotherapy was an effective, feasible, and safe option for treating HCC in patients not suitable for other treatment options.
Keyphrases
- phase ii
- end stage renal disease
- clinical trial
- open label
- newly diagnosed
- free survival
- phase ii study
- ejection fraction
- chronic kidney disease
- double blind
- prognostic factors
- peritoneal dialysis
- patient reported outcomes
- primary care
- case report
- patients undergoing
- squamous cell carcinoma
- deep learning
- replacement therapy
- smoking cessation
- study protocol
- rectal cancer
- radiation therapy
- locally advanced