Calcium Electroporation for Hemostasis in Gastric NeoplasmsGASTRIC-CaEPNCT07647731
Endoscopic Calcium Electroporation in Gastric Tumors
A study testing Endoscopy Calcium Electroporation in people with Calcium Electroporation for Hemostasis in Gastric Neoplasms, run by Hospital del Rio Hortega.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcium Electroporation for Hemostasis in Gastric Neoplasms
- What is being tested?
- Endoscopy Calcium Electroporation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- 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.
- In addition, participants must meet at least one of the following conditions:
Show all 10Show fewer
- Patients considered unsuitable for surgical and/or oncological treatment with curative or palliative intent due to advanced age, frailty, or significant comorbidities (Charlson Comorbidity Index ≥3 and/or ECOG Performance Status ≥2), following multidisciplinary team assessment.
- Patients with metastatic disease receiving palliative systemic therapy in whom CaEP is indicated for symptomatic control of tumor-related gastrointestinal bleeding.
- Patients receiving neoadjuvant therapy who develop tumor-related gastrointestinal bleeding requiring bleeding control to avoid interruption of systemic treatment prior to surgery.
- Patients who decline surgical and/or oncological treatment when CaEP is considered appropriate for symptomatic control of gastrointestinal bleeding.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- 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.
- Medical contraindication to deep sedation or therapeutic upper gastrointestinal endoscopy.
- Estimated life expectancy of less than 1 month.
- Refusal or inability to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Endoscopic Calcium Electroporation in Gastric Tumors: A Minimally Invasive Treatment Strategy
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.
Read more
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.
Read the detailed description
Study Design This is a prospective, multicenter, non-randomized, non-pharmacological interventional study with longitudinal follow-up designed to evaluate the efficacy and safety of endoscopic calcium electroporation (CaEP) for the management of tumor-related gastrointestinal bleeding in patients with gastric cancer.
Participants will undergo two scheduled sessions of endoscopic calcium electroporation. The second treatment session will be performed 4 weeks after the initial procedure unless a clinical or technical contraindication arises.
Patient recruitment and follow-up are planned from JUNE 2026 through May 2028. Data analysis and dissemination of results will take place between June 2028 and December 2028.
Study Population Adult patients (≥18 years) with histologically confirmed gastric cancer presenting with iron-deficiency anemia and/or gastrointestinal bleeding attributable to the primary tumor will be prospectively enrolled after providing written informed consent.
The study will be conducted in the Gastroenterology Departments of participating hospitals.
Sample Size Based on previously published data suggesting a 90% improvement in quality of life and reduction in transfusion requirements following calcium electroporation, a clinically meaningful improvement of 20% was assumed. Using a two-sided alpha error of 0.05 and a statistical power of 80%, the required sample size was calculated as 25 evaluable patients. Allowing for an anticipated 10% loss to follow-up, the target enrollment is 28 participants.
Intervention Procedures Baseline Assessment
Before treatment, participants will undergo:
- Clinical evaluation and medical history review.
- Symptom assessment, including pain evaluation using a visual analogue scale (VAS).
- Quality-of-life assessment using the EORTC QLQ-C30 questionnaire.
- Nutritional assessment, including anthropometric measurements and laboratory testing.
- Complete blood analysis, including hemoglobin, hematocrit, albumin, prealbumin, iron studies, vitamin levels, electrolytes, and metabolic profile.
- Endoscopic tumor assessment with photographic documentation and tumor size estimation.
Tumor biopsies, non-tumoral gastric mucosal biopsies (when technically feasible), and peripheral blood samples will be collected before the first treatment and again prior to the second treatment at week 4.
Calcium 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.
After treatment, patients will remain under observation for 60-120 minutes for monitoring of immediate adverse events, including pain, bleeding, nausea, or perforation.
Follow-up A telephone safety assessment will be conducted 1 week after each treatment session.
The second CaEP treatment will be performed 4 weeks after the first procedure and will include repeat clinical assessment, laboratory evaluation, and biological sample collection.
Subsequently, patients will undergo monthly follow-up visits (in-person or by telephone, according to clinical status) to record bleeding episodes, transfusion requirements, hospital admissions, and clinical outcomes.
From month 3 onward, follow-up assessments will occur every 12 weeks (weeks 12, 24, 36, and 48) and will include:
- Clinical evaluation.
- Laboratory testing.
- Symptom assessment.
- EORTC QLQ-C30 quality-of-life questionnaire.
- Upper gastrointestinal endoscopy.
- Computed tomography (CT) imaging. Additional CaEP treatments may be offered in cases of recurrent tumor-related bleeding or anemia after exclusion of alternative causes. Retreatment may be considered in patients experiencing a decrease in hemoglobin of ≥2 g/dL from previous assessments or clinical evidence of recurrent gastrointestinal bleeding.
- Being tested
- Endoscopy Calcium Electroporation
- Keywords
- BLEEDING, CALCIUM ELECTROPORATION, gastric neoplasms, hemostasis
- Medical subject headings
- Hemorrhage, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy Calcium ElectroporationProcedure or surgery
Calcium 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 electroporationDevice
Also called Endoscopic electrochemotherapy
Calcium 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.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic calcium electroporation | Experimental | Participants will undergo two scheduled sessions of endoscopic calcium electroporation. The second treatment session will be performed 4 weeks after the initial procedure unless a clinical or technical contraindication arises. Receives: Procedure: Endoscopy Calcium Electroporation; Device: Endoscopy Calcium electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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.
Measured: Baseline (prior to the first CaEP treatment) and Week 4 (prior to the second CaEP treatment).
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Calcium Electroporation for Hemostasis in Gastric NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multicenter, non-randomized, non-pharmacological interventional study with longitudinal follow-up designed to evaluate the efficacy and safety of endoscopic calcium electroporation (CaEP) for the management of tumor-related gastrointestinal bleeding in patients with gastric cancer. Participants will undergo two scheduled sessions of endoscopic calcium electroporation. The second treatment session will be performed 4 weeks after the initial procedure unless a clinical or technical contraindication arises.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Henar Núñez Rodriguez, MD PhD, Hospital del Rio Hortega
- Investigators
- Mª Henar Núñez Rodríguez, Principal investigator, Digestive Department, Hospital Rio Hortega, Valladolid, Sapin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647731
- Sponsor's protocol ID
- PI-GR-25- 485-H
- Acronym
- GASTRIC-CaEP
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristics (e.g., age and sex). Baseline clinical characteristics, including ECOG Performance Status, Charlson Comorbidity Index, and disease stage. Laboratory parameters, including hematological, biochemical, and nutritional markers collected according to the study protocol. Symptom and quality-of-life assessments, including EORTC QLQ-C30 and Visual Analog Scale (VAS) scores. Tumor characteristics and endoscopic findings. Treatment-related data, including calcium electroporation (CaEP) procedural parameters, calcium dose administered, number of treatment sessions, and technical treatment characteristics. Clinical outcomes, including control of tumor-related gastrointestinal bleeding, transfusion requirements, hospital admissions, adverse events, progression, and survival outcomes. De-identified molecular, proteomic, and biomarker data generated from tumor tissue, non-tumoral gastric mucosa, and peripheral blood samples.
Publications
Broholm M, Vogelsang R, Bulut M, Gogenur M, Stigaard T, Orhan A, Schefte X, Fiehn AMK, Gehl J, Gogenur I. Neoadjuvant calcium electroporation for potentially curable colorectal cancer. Surg Endosc. 2024 Feb;38(2):697-705. doi: 10.1007/s00464-023-10557-1. Epub 2023 Nov 28.
PubMed 38017160Egeland C, Baeksgaard L, Gehl J, Gogenur I, Achiam MP. Palliative Treatment of Esophageal Cancer Using Calcium Electroporation. Cancers (Basel). 2022 Oct 27;14(21):5283. doi: 10.3390/cancers14215283.
PubMed 36358702Falk H, Matthiessen LW, Wooler G, Gehl J. Calcium electroporation for treatment of cutaneous metastases; a randomized double-blinded phase II study, comparing the effect of calcium electroporation with electrochemotherapy. Acta Oncol. 2018 Mar;57(3):311-319. doi: 10.1080/0284186X.2017.1355109. Epub 2017 Aug 17.
PubMed 28816072Forde PF, Sadadcharam M, Bourke MG, Conway TA, Guerin SR, de Kruijf M, O'Sullivan GC, Impellizeri J, Clover AJP, Soden DM. Preclinical evaluation of an endoscopic electroporation system. Endoscopy. 2016 May;48(5):477-483. doi: 10.1055/s-0042-101343. Epub 2016 Apr 4.
PubMed 27042930Vissing M, Sinius Pouplier S, Munch Larsen L, Krog Frandsen S, Lodin A, Laenkholm AV, Gehl J. Immune cell populations in the tumour environment following calcium electropora-tion for cutaneous metastasis: a histopathological study. Acta Oncol. 2024 May 28;63:398-410. doi: 10.2340/1651-226X.2024.19462.
PubMed 38804839Bonura GF, Gualandi N, Soriani P, Cortegoso Valdivia P, Gabbani T, Zadro V, Indulti F, Frassanito G, de Nucci G, Manno M. Pioneering Endoscopic Calcium-Electroporation in Gastric Cancer: A Case Series of an Emerging Therapeutic Approach. Diseases. 2025 Oct 15;13(10):340. doi: 10.3390/diseases13100340.
PubMed 41149074Adeyeye A, Olabintan O, Ayubi H, Gao H, Saini A, Emmanuel A, Hayee B, Haji A. Palliative Luminal Treatment of Colorectal Cancer Using Endoscopic Calcium-Electroporation: First Case Series from United Kingdom. J Clin Med. 2025 Jun 11;14(12):4138. doi: 10.3390/jcm14124138.
PubMed 40565892
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic Calcium Electroporation in Gastric Tumors: A Minimally Invasive Treatment Strategy
- ClinicalTrials.gov ID
- NCT07647731
- Acronym / sponsor ID
- GASTRIC-CaEP / PI-GR-25- 485-H
- Keywords
- BLEEDING, CALCIUM ELECTROPORATION, gastric neoplasms, hemostasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design This is a prospective, multicenter, non-randomized, non-pharmacological interventional study with longitudinal follow-up designed to evaluate the efficacy and safety of endoscopic calcium electroporation (CaEP) for the management of tumor-related gastrointestinal bleeding in patients with gastric cancer.
Participants will undergo two scheduled sessions of endoscopic calcium electroporation. The second treatment session will be performed 4 weeks after the initial procedure unless a clinical or technical contraindication arises.
Patient recruitment and follow-up are planned from JUNE 2026 through May 2028. Data analysis and dissemination of results will take place between June 2028 and December 2028.
Study Population Adult patients (≥18 years) with histologically confirmed gastric cancer presenting with iron-deficiency anemia and/or gastrointestinal bleeding attributable to the primary tumor will be prospectively enrolled after providing written informed consent.
The study will be conducted in the Gastroenterology Departments of participating hospitals.
Sample Size Based on previously published data suggesting a 90% improvement in quality of life and reduction in transfusion requirements following calcium electroporation, a clinically meaningful improvement of 20% was assumed. Using a two-sided alpha error of 0.05 and a statistical power of 80%, the required sample size was calculated as 25 evaluable patients. Allowing for an anticipated 10% loss to follow-up, the target enrollment is 28 participants.
Intervention Procedures Baseline Assessment
Before treatment, participants will undergo:
- Clinical evaluation and medical history review.
- Symptom assessment, including pain evaluation using a visual analogue scale (VAS).
- Quality-of-life assessment using the EORTC QLQ-C30 questionnaire.
- Nutritional assessment, including anthropometric measurements and laboratory testing.
- Complete blood analysis, including hemoglobin, hematocrit, albumin, prealbumin, iron studies, vitamin levels, electrolytes, and metabolic profile.
- Endoscopic tumor assessment with photographic documentation and tumor size estimation.
Tumor biopsies, non-tumoral gastric mucosal biopsies (when technically feasible), and peripheral blood samples will be collected before the first treatment and again prior to the second treatment at week 4.
Calcium 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.
After treatment, patients will remain under observation for 60-120 minutes for monitoring of immediate adverse events, including pain, bleeding, nausea, or perforation.
Follow-up A telephone safety assessment will be conducted 1 week after each treatment session.
The second CaEP treatment will be performed 4 weeks after the first procedure and will include repeat clinical assessment, laboratory evaluation, and biological sample collection.
Subsequently, patients will undergo monthly follow-up visits (in-person or by telephone, according to clinical status) to record bleeding episodes, transfusion requirements, hospital admissions, and clinical outcomes.
From month 3 onward, follow-up assessments will occur every 12 weeks (weeks 12, 24, 36, and 48) and will include:
- Clinical evaluation.
- Laboratory testing.
- Symptom assessment.
- EORTC QLQ-C30 quality-of-life questionnaire.
- Upper gastrointestinal endoscopy.
- Computed tomography (CT) imaging. Additional CaEP treatments may be offered in cases of recurrent tumor-related bleeding or anemia after exclusion of alternative causes. Retreatment may be considered in patients experiencing a decrease in hemoglobin of ≥2 g/dL from previous assessments or clinical evidence of recurrent gastrointestinal bleeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multicenter, non-randomized, non-pharmacological interventional study with longitudinal follow-up designed to evaluate the efficacy and safety of endoscopic calcium electroporation (CaEP) for the management of tumor-related gastrointestinal bleeding in patients with gastric cancer. Participants will undergo two scheduled sessions of endoscopic calcium electroporation. The second treatment session will be performed 4 weeks after the initial procedure unless a clinical or technical contraindication arises.
| Arm | Type | Receives |
|---|---|---|
| endoscopic calcium electroporation | Experimental | Procedure: Endoscopy Calcium Electroporation, Device: Endoscopy Calcium electroporationParticipants will undergo two scheduled sessions of endoscopic calcium electroporation. The second treatment session will be performed 4 weeks after the initial procedure unless a clinical or technical contraindication arises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Patients considered unsuitable for surgical and/or oncological treatment with curative or palliative intent due to advanced age, frailty, or significant comorbidities (Charlson Comorbidity Index ≥3 and/or ECOG Performance Status ≥2), following multidisciplinary team assessment.
Key exclusion criteria (8 listed)
- 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.
- Medical contraindication to deep sedation or therapeutic upper gastrointestinal endoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy Calcium ElectroporationCalcium 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. | Procedure or surgery | endoscopic calcium electroporation |
| Endoscopy Calcium electroporationAlso: Endoscopic electrochemotherapyCalcium 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. | Device | endoscopic calcium electroporation |
Primary outcome
Proportion of participants achieving clinical hemostasis
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.
Number of participants with episodes of hematemesis, melena, or hematochezia recorded during follow-up, as assessed by clinical evaluation and medical record review.
4 secondary outcomes
Differential protein expression in tumor tissue and peripheral blood following calcium electroporation (CaEP).
Time frame: Baseline (prior to the first CaEP treatment) and Week 4 (prior to the second CaEP treatment).
Need for Rescue Hemostatic Intervention
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.
Change From Baseline in Maximum Tumor Diameter Measured by Computed Tomography
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.
Change From Baseline in Endoscopic Tumor Size
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 38017160Broholm M, Vogelsang R, Bulut M, Gogenur M, Stigaard T, Orhan A, Schefte X, Fiehn AMK, Gehl J, Gogenur I. Neoadjuvant calcium electroporation for potentially curable colorectal cancer. Surg Endosc. 2024 Feb;38(2):697-705. doi: 10.1007/s00464-023-10557-1. Epub 2023 Nov 28.
- Results publication: PubMed 36358702Egeland C, Baeksgaard L, Gehl J, Gogenur I, Achiam MP. Palliative Treatment of Esophageal Cancer Using Calcium Electroporation. Cancers (Basel). 2022 Oct 27;14(21):5283. doi: 10.3390/cancers14215283.
- Results publication: PubMed 28816072Falk H, Matthiessen LW, Wooler G, Gehl J. Calcium electroporation for treatment of cutaneous metastases; a randomized double-blinded phase II study, comparing the effect of calcium electroporation with electrochemotherapy. Acta Oncol. 2018 Mar;57(3):311-319. doi: 10.1080/0284186X.2017.1355109. Epub 2017 Aug 17.
- Results publication: PubMed 27042930Forde PF, Sadadcharam M, Bourke MG, Conway TA, Guerin SR, de Kruijf M, O'Sullivan GC, Impellizeri J, Clover AJP, Soden DM. Preclinical evaluation of an endoscopic electroporation system. Endoscopy. 2016 May;48(5):477-483. doi: 10.1055/s-0042-101343. Epub 2016 Apr 4.
- Results publication: PubMed 38804839Vissing M, Sinius Pouplier S, Munch Larsen L, Krog Frandsen S, Lodin A, Laenkholm AV, Gehl J. Immune cell populations in the tumour environment following calcium electropora-tion for cutaneous metastasis: a histopathological study. Acta Oncol. 2024 May 28;63:398-410. doi: 10.2340/1651-226X.2024.19462.
- Results publication: PubMed 41149074Bonura GF, Gualandi N, Soriani P, Cortegoso Valdivia P, Gabbani T, Zadro V, Indulti F, Frassanito G, de Nucci G, Manno M. Pioneering Endoscopic Calcium-Electroporation in Gastric Cancer: A Case Series of an Emerging Therapeutic Approach. Diseases. 2025 Oct 15;13(10):340. doi: 10.3390/diseases13100340.
- Results publication: PubMed 40565892Adeyeye A, Olabintan O, Ayubi H, Gao H, Saini A, Emmanuel A, Hayee B, Haji A. Palliative Luminal Treatment of Colorectal Cancer Using Endoscopic Calcium-Electroporation: First Case Series from United Kingdom. J Clin Med. 2025 Jun 11;14(12):4138. doi: 10.3390/jcm14124138.
- Individual participant dataSharing planned: Yes. Demographic characteristics (e.g., age and sex). Baseline clinical characteristics, including ECOG Performance Status, Charlson Comorbidity Index, and disease stage. Laboratory parameters, including hematological, biochemical, and nutritional markers collected according to the study protocol. Symptom and quality-of-life assessments, including EORTC QLQ-C30 and Visual Analog Scale (VAS) scores. Tumor characteristics and endoscopic findings. Treatment-related data, including calcium electroporation (CaEP) procedural parameters, calcium dose administered, number of treatment sessions, and technical treatment characteristics. Clinical outcomes, including control of tumor-related gastrointestinal bleeding, transfusion requirements, hospital admissions, adverse events, progression, and survival outcomes. De-identified molecular, proteomic, and biomarker data generated from tumor tissue, non-tumoral gastric mucosa, and peripheral blood samples.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mª Henar Núñez Rodríguez principal investigator
Digestive Department, Hospital Rio Hortega, Valladolid, Sapin
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy Calcium Electroporation in people with Calcium Electroporation for Hemostasis in Gastric Neoplasms, run by Hospital del Rio Hortega.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mª Henar Núñez Rodríguez, MD PhD (34 983 420 400 ext. 84433, henarnrod@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving clinical hemostasis (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07647731, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.