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RECRUITING
NCT06232434
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-06-20

Completion Date

2025-12

Last Updated

2025-06-22

Healthy Volunteers

No

Interventions

DRUG

Prospidelong

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.

PROCEDURE

chemotherapy

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