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.
Parallel
Prospidelong
DrugProspidium 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.
chemotherapy
Procedure/Surgeryafter 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
increased survival
The criterion for the effectiveness of a single intraperitoneal administration of the investigational drug Prospidelong in patients with disseminated gastric cancer will be an increase in progression-free survival after use of the investigational drug Prospidelong. Progression of disseminated peritoneal tumors with documented evidence of an increase in the grade of disseminated peritoneal tumors (compared to baseline) on non-invasive intrascopic imaging (CT or MRI) will be considered as events in the calculation of progression-free survival for this clinical trial. abdominal cavity) and/or second-look laparotomy. In the latter case, assessment of the peritoneal tumor index P.H. will be mandatory. Sugarbaker. Second-look laparotomy will be planned in patients with no evidence of progression of the tumor process according to multislice computed tomography or magnetic resonance imaging of the abdominal cavity.
Ultrasound and/or computed tomography of the abdominal cavity (if necessary)
the progression or stabilization of the disease is assessed during treatment (systemic chemotherapy) by identifying distant metastases (liver, lungs) or an increase in their number, the appearance or increase in the amount of ascitic fluid in the dynamics of observation and/or the presence of disseminates
detailed general blood test
Blood samples will be collected for the analysis of hemoglobin, erythrocytes, leukocytes, segmented neutrophils, platelets level
blood chemistry
Blood samples will be collected for the analysis of total protein, creatinine, urea, bilirubin, AST, ALT level
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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