Clinical trial · Interventional
Electrochemotherapy for Non-curable Gastric Cancer
NCT04139070CI-TRIAL-00046729unknownPhase 1ClinicalTrials.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)
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.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treátment group
- description
- 8 patients are expected to be included in this study. The patients will be treated once with bleomycin in combination with elektroporation
- interventionNames
- Drug: Bleomycin
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events (CTCAE)
- timeFrame
- 3 months
- description
- 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).
Secondary outcomes (4)
- measure
- Histopathological characterization of tumor biopsies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.