Endoscopic Calcium Electroporation in Gastric Tumors

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

Interventions

PROCEDURE

Endoscopy Calcium Electroporation

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.

DEVICE

Endoscopy Calcium electroporation

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.

Sponsors & Collaborators

• Hospital del Rio Hortega

  lead OTHER

Principal Investigators

• Mª Henar Núñez Rodríguez · Digestive Department, Hospital Rio Hortega, Valladolid, Sapin

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2029-06-30

Completion

2031-12-31