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.
Gastric cancer without transition to the esophagus with peritoneal dissemination sT1-4N0-3M1.
Life expectancy of at least 6 months
Physical status on the ECOG scale 0 - 1.
The age of patients is from 18 to 75 years.
Pregnancy and lactation.
The presence of a primary multiple (synchronous or metachronous) malignant tumor. The exception is for patients who were treated for basal cell or squamous cell skin cancer, cervical cancer in situ, or other tumors more than 5 years ago and are expected to be completely cured.
Presence of severe concomitant diseases in the stage of decompensation;
Family relationships between the patient and the center staff.
Research Institute for Physical Chemical Problems of the Belarusian State University
Lead sponsor
N.N. Alexandrov National Cancer Centre
Collaborator
Unitary Enterprise UNITEHPROM BSU
Collaborator