Endoscopic Calcium Electroporation in Gastric Tumors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital del Rio Hortega
About this trial
Brief Summary Background
Gastric cancer (GC) remains a major global public health challenge, ranking as the fifth most common malignancy worldwide and the third leading cause of cancer-related mortality. In 2018, approximately 1 million new cases and 783,000 deaths were reported globally. The median age at diagnosis is around 60 years, with relatively few cases occurring in younger patients.
Despite advances in systemic therapies, up to 60% of patients are diagnosed with advanced-stage disease, and approximately 20% present with significant comorbidities that limit available treatment options. This highlights the need for effective, safe, and well-tolerated therapeutic alternatives, particularly for frail patients and those with advanced disease.
In this context, calcium electroporation (CaEP) has emerged as a novel therapeutic approach with the potential to address an important unmet clinical need. CaEP is a local, minimally invasive treatment that may provide effective control of debilitating symptoms such as tumor-related gastrointestinal bleeding, while improving patients' functional status and quality of life. Importantly, these benefits may be achieved without the additional morbidity and mortality associated with more invasive therapeutic interventions. The implementation of CaEP could represent a significant advance in the management of gastric cancer, particularly in patients with limited treatment options.
Primary Objective
To evaluate the efficacy and safety of calcium electroporation (CaEP) in controlling gastrointestinal bleeding secondary to gastric cancer in patients undergoing palliative treatment, either in combination with systemic therapy or in clinical situations where control of tumor-related bleeding is required.
Study Design
This is a multicenter, non-randomized, non-pharmacological interventional study with longitudinal follow-up.
The intervention consists of two scheduled sessions of endoscopic calcium electroporation (CaEP). The second procedure will be performed 4 weeks after the first treatment unless contraindicated for clinical reasons.
Primary Outcome Measure
Clinical control of gastrointestinal bleeding secondary to gastric neoplasia.
Study Population
Patients with histologically confirmed gastric cancer who present with gastrointestinal bleeding symptoms or secondary anemia will be prospectively enrolled.
Eligible participants will include patients who are candidates for palliative treatment, either as monotherapy or in combination with systemic medical treatment and/or radiotherapy. Patients experiencing tumor-related bleeding during neoadjuvant treatment prior to surgery may also be included.
Estimated Enrollment
A total sample size of 25 evaluable patients is required. Assuming a 10% loss to follow-up, the planned enrollment is 28 patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Histologically confirmed gastric malignancy.
Presence of anemia and/or gastrointestinal bleeding secondary to gastric cancer.
Ability and willingness to provide written informed consent.
Disqualifiers
Pregnancy or breastfeeding.
Presence of an endoluminal prosthesis within the intended treatment area.
Implanted electrical devices (e.g., pacemakers, implantable cardioverter-defibrillators) when temporary deactivation is not feasible or procedural safety cannot be guaranteed.
Uncorrectable coagulation disorders.
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopy Calcium Electroporation
Procedure/SurgeryCalcium Electroporation Procedure The procedure will be performed on an outpatient basis under deep sedation with standard monitoring and supplemental oxygen. Following endoscopic evaluation of the lesion, intratumoral calcium gluconate (220 mM; 9 mg/mL) will be injected using a 23-gauge needle. The administered volume will be calculated according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE) guidelines and adjusted to tumor size. Electroporation will then be performed using the EndoVE® device connected to the distal end of the endoscope and the ePORE® pulse generator. Electrical pulses will be delivered to cover the entire tumor surface whenever technically feasible. Procedural parameters, including treated tumor percentage, number of pulses, impedance, and applied voltage, will be recorded.
Endoscopy Calcium electroporation
DeviceCalcium Electroporation Procedure The procedure will be performed on an outpatient basis under deep sedation with standard monitoring and supplemental oxygen. Following endoscopic evaluation of the lesion, intratumoral calcium gluconate (220 mM; 9 mg/mL) will be injected using a 23-gauge needle. The administered volume will be calculated according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE) guidelines and adjusted to tumor size. Electroporation will then be performed using the EndoVE® device connected to the distal end of the endoscope and the ePORE® pulse generator. Electrical pulses will be delivered to cover the entire tumor surface whenever technically feasible. Procedural parameters, including treated tumor percentage, number of pulses, impedance, and applied voltage, will be recorded.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: endoscopic calcium electroporationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of participants achieving clinical hemostasis
Number of participants with episodes of hematemesis, melena, or hematochezia recorded during follow-up, as assessed by clinical evaluation and medical record review.
Time frame
From the first CaEP treatment through 24 months of follow-up, including monthly assessments after the two scheduled procedures and quarterly assessments from Month 3 onward.Secondary outcomes
1
Differential protein expression in tumor tissue and peripheral blood following calcium electroporation (CaEP).
To identify differentially expressed proteins in tumor biopsy specimens and peripheral blood samples and to evaluate changes in protein expression profiles following treatment with calcium electroporation.
Time frame
Baseline (prior to the first CaEP treatment) and Week 4 (prior to the second CaEP treatment).2
Need for Rescue Hemostatic Intervention
Percentage of participants requiring additional endoscopic, radiological, or surgical hemostatic treatment for recurrent gastric tumor-related bleeding during follow-up.
Time frame
From the first CaEP treatment through 24 months of follow-up, including monthly assessments after the two scheduled procedures and quarterly assessments from Month 3 onward.3
Change From Baseline in Maximum Tumor Diameter Measured by Computed Tomography
Change in maximum tumor diameter (mm) from baseline to follow-up, measured on contrast-enhanced computed tomography scans according to RECIST 1.1 criteria.
Time frame
From the first CaEP treatment through 24 months of follow-up, including monthly assessments after the two scheduled procedures and quarterly assessments from Month 3 onward.4
Change From Baseline in Endoscopic Tumor Size
Change in the maximum endoscopic tumor diameter (mm) from baseline to follow-up, measured during upper gastrointestinal endoscopy using endoscopic size estimation and photographic documentation.
Time frame
From the first CaEP treatment through 24 months of follow-up, including monthly assessments after the two scheduled procedures and quarterly assessments from Month 3 onward.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: