Endoscopic Calcium Electroporation in Gastric Tumors

NCT07647731 | Not Yet Recruiting

• 1 other identifier: PI-GR-25- 485-H
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Calcium Electroporation for Hemostasis in Gastric Neoplasms

Keywords

BLEEDING; CALCIUM ELECTROPORATION; gastric neoplasms; hemostasis

Outcome Measures

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.

  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).

  Baseline (prior to the first CaEP treatment) and Week 4 (prior to the second CaEP treatment).

• Need for Rescue Hemostatic Intervention

  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

  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

  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.

Study Arms (1)

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.

Procedure: Endoscopy Calcium Electroporation; Device: Endoscopy Calcium electroporation

Interventions

Endoscopy Calcium electroporation PROCEDURE

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.

endoscopic calcium electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Related Publications (7)

• 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.

  PMID: 38017160 RESULT

• Egeland 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.

  PMID: 36358702 RESULT

• Falk 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.

  PMID: 28816072 RESULT

• Forde 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.

  PMID: 27042930 RESULT

• Vissing 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.

  PMID: 38804839 RESULT

• Bonura 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.

  PMID: 41149074 RESULT

• Adeyeye 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.

  PMID: 40565892 RESULT

MeSH Terms

Conditions

Hemorrhage; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Mª Henar Núñez Rodríguez

  Digestive Department, Hospital Rio Hortega, Valladolid, Sapin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mª Henar Núñez Rodríguez, MD PhD

CONTACT

34 983 420 400; henarnrod@yahoo.es

Mª Henar Núñez Rodriguez, MD PhD

CONTACT

34 983 420 400; henarnrod@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Digestive Disease Doctor, MD PhD

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6-12 months after publication of the primary study results and will remain available for at least 5 years.
• Access Criteria: Access to de-identified individual participant data will be granted to qualified researchers upon submission of a methodologically sound research proposal. Requests will be reviewed by the study investigators and must comply with applicable ethical, legal, and data protection requirements. Data sharing agreements may be required before access is granted.