This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of electrochemotherapy for non-curable gastric cancer.
This is an explorative, phase I clinical trial. Aim of this study is to establish the safety of electrochemotherapy as a palliative treatment for advanced (non-curable) gastric cancer. The study involves recruitment of 8 patients with histologically verified and non-curable gastric cancer (including Siewert Type II and II). Patients will be recruited from Department of Surgery, Odense University Hospital and from Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Electrochemotherapy will take place at Department of Surgery, Zealand University Hospital. After the treatment patients will be referred to Odense University Hospital for follow-up. Electrochemotherapy will be performed as an additive treatment to standard oncological care. Patients are treated once and will be followed with endoscopy, biopsies, scans, blood samples and questionnaires after 4-6 weeks and 8-12 weeks with a minimum interval of 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Electroporation in combination with systemically administered bleomycin
Department of Surgery, Zealand University Hospital
Køge, Denmark
RECRUITINGIncidence of Treatment-Emergent Adverse Events (CTCAE)
Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: 3 months
Histopathological characterization of tumor biopsies
Endoscopic biopsies will be collected. Standard histology (Characterization of tumor tissue, fibrosis) will be performed and regression grade according to current standards
Time frame: 3 months
Gene expression analysis
Specific immunohistochemical staining for PD-1/PD-L1, additionally, samples will be stained for CD3, CD8 and CD28. Finally, gene expression analyses will be performed using the Nano String method. In this current study, we plan to use the PanCancer IO 360 gene expression panel to analyze mRNA. This is a - 770-plex gene expression panel covering the complex interplay between tumor, microenvironment and immune response in cancer, including T and B cell activation and inhibition,, adhesion molecules, chemokines and cytokines, and pattern recognition receptors. This is a predefined gene panel and does not involve extensive mapping of the human genome.
Time frame: 3 months
Quality of life with "The European Organization for Research and Treatment of Cancer quality of life questionnaire" (EORTC QLQ-C30)
Quality of Life questionnaires will be collected at baseline and after 8-12 weeks using the EORTC QLQ-C30 questionnaire. The questionnaire consist of 30 questions with a maximum score of 126 points and a minimum score of 30 points.
Time frame: 3 months
Tumor volume
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Tumor response will be evaluated through endoscopic ultrasound (EUS) to measure tumor volume before and after treatment
Time frame: 3 months