Endoscopic Calcium Electroporation in Gastric Tumors

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

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.

Exclusion Criteria:

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

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