Overview

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 Pat

Status:
RECRUITING

Trial end date:
2025-12-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE2

Details

Lead Sponsor:

Research Institute for Physical Chemical Problems of the Belarusian State University

Collaborators:

N.N. Alexandrov National Cancer Centre
Unitary Enterprise UNITEHPROM BSU

Treatments:

Drug Therapy