RecruitingPhase 2Phase 3NCT06232434

An Open Prospective Randomized Clinical Study of the Effectiveness, Tolerability and Safety of a Single Intraperitoneal Use of the Drug "Prospidelong, Powder for the Preparation of a Gel for Topical Use, 1000 mg in Vials, Package No. 1" in Patients With Disseminated Gastric Cancer, Phase I-II

Sponsor

Research Institute for Physical Chemical Problems of the Belarusian State University

Enrollment

120 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer With Peritoneal Dissemination

Summary

It is planned to conduct an open-label, prospective, randomized clinical study of the efficacy, tolerability and safety of a single intraperitoneal administration of the investigational drug Prospidelong at a dose of 4000 mg (2000 mg in terms of prospidium chloride) in patients with disseminated gastric cancer. In total, the study plans to include 120 patients aged 18 to 75 years inclusive, including 60 patients in the study group and 60 in the comparison group. The study consists of daily examination of patients throughout the entire period of hospitalization and subsequent visits.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing a drug called Prospidelong (given directly into the abdominal cavity as a gel) for patients with gastric (stomach) cancer that has spread to the lining of the abdomen (peritoneal spread). **You may be eligible if...** - You have stomach cancer that has spread within the abdominal cavity - You are 18 to 75 years old - You are in reasonably good general health (ECOG 0–1) - Your life expectancy is at least 6 months - You do not have other serious uncontrolled illnesses **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have another active cancer - You are allergic to components of the study drug - You have severe heart disease or a history of epilepsy - You have a family relationship with the research center staff Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGProspidelong

Prospidium chloride (in the form of prospidelong (a mixture of prospidium chloride and dextran sodium salt phosphate containing carbamate groups in a 1:1 ratio)) - 1000 mg.

PROCEDUREchemotherapy

after diagnostic laparotomy/laparoscopy, systemic chemotherapy in accordance with the clinical protocol "Algorithms for the diagnosis and treatment of malignant neoplasms" (approved by Resolution of the Ministry of Health of the Republic of Belarus No. 60 of 07/06/2018), namely the section regulating the treatment of patients suffering from metastatic gastric cancer with a degree of prevalence tumor process corresponding to sT1-4N0-3M1

Locations(1)

The state institution N. N. Alexandrov National Cancer Centre of Belarus

Minsk, Minsk City, Belarus

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NCT06232434