Clinical trial NCT04139070: Electrochemotherapy for Non-curable Gastric Cancer
Official title: Electrochemotherapy for Non-curable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastric Cancer
Keywords: Electrochemotherapy
Palliative treatment
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2019-10-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients must be mentally capable of understanding the information given.
* Patients must give written informed consent.
* Histologically verified gastric cancer (adenocarcinoma, including Siewert Type II and II)
* Non-curable disease according to MDT decision
* Age ≥ 18 years.
* ASA class I-III (Classification of the American Society of Anesthesiology)
* Thrombocytes ≥ 50 billions/l, INR \>1,2. Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K or administration of freshly frozen plasma.
* Performance status ECOG/WHO ≤2

Exclusion Criteria:

* Locally advanced non-metastatic EGJ/GC patients that may become resectable after pretreatment
* Inability to perform upper endoscopy with attached equipment.
* Uncorrectable coagulation disorder
* Patients with ICD or pacemaker units
* Myocardial insufficiency, defined as NYHA class \>2
* Concurrent treatment with an investigational medicinal product.
* Renal impairment, defined as GFR \<40 ml/min
* Pregnancy
* Concurrent inclusion in a medical trial where the intervention may affect safety measures used in the current protocol.
* Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
* Acute pulmonary infection.
* Medical history of severe pulmonary disease.
* Previous allergic reactions to bleomycin.
* Previous cumulative dose of bleomycin exceeding 250mg/m2.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (CTCAE)
timeFrame: 3 months
Secondary outcomes:
measure: Histopathological characterization of tumor biopsies
timeFrame: 3 months
measure: Gene expression analysis
timeFrame: 3 months
measure: Quality of life with "The European Organization for Research and Treatment of Cancer quality of life questionnaire" (EORTC QLQ-C30)
timeFrame: 3 months
measure: Tumor volume
timeFrame: 3 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Surgery, Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: ismail Gögenur, DMSc
role: PRINCIPAL_INVESTIGATOR
References: