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

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.

Timeline

Start

2025-06-20

Primary completion

2025-12

Completion

2025-12

Publications

• Results Solomevich SO, Bychkovsky PM, Yurkshtovich TL, Golub NV, Mirchuk PY, Revtovich MY, Shmak AI. Biodegradable pH-sensitive prospidine-loaded dextran phosphate based hydrogels for local tumor therapy. Carbohydr Polym. 2019 Dec 15;226:115308. doi: 10.1016/j.carbpol.2019.115308. Epub 2019 Sep 9.

Drugs

Indications