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

Recruiting now · Phase 2/Phase 3

Conditions studied: Gastric Cancer With Peritoneal Dissemination

In brief

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 facts

Study ID

NCT06232434

Run by

Research Institute for Physical Chemical Problems of the Belarusian State University

People needed

120

Starts

2025-06-20

Expected to finish

2025-12-01

Last updated by the study team

2025-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Absence of severe concomitant diseases in the decompensation stage.
• Availability of written informed consent from the patient to participate in the study.
• The ability of the patient and the personnel caring for him to comply with the instructions of the research physician and comply with the study design.

You may not qualify if…

• 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.
• Allergy to components of the study drug.
• Refusal of the patient from the proposed treatment method.
• Presence of heart disease class III or IV according to the New York Heart Association classification or a history of myocardial infarction within 6 months before the 1st day of the study.
• Any history of epileptic seizures.
• Severe diseases, including those with severe symptoms, untreated inflammatory and infectious processes, due to which the patient cannot receive treatment in accordance with the study protocol.
• Chronic liver and/or kidney failure.
• Legal incapacity or other circumstances due to which the patient or his immediate family are unable to understand the nature, scope and possible consequences of the treatment being carried out
• Socioeconomic or geographic circumstances that cannot guarantee adequate compliance with protocol requirements for treatment and follow-up.
• History of abuse of alcohol or any chemical substances for 2 years up to the 10th day before the start of the study.
• Patient participation in another clinical trial.
• Non-inclusion criteria based on survey data:
• Acute bleeding from the tumor.
• Level of peripheral blood leukocytes less than 1.5 × 109 per l, platelets less than 75.0 × 109 per l.
• Hemoglobin less than 80g per l.
• Positive tests for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
• Severe liver dysfunction - AST and ALT levels exceed the upper limit of normal by 5 times or more, bilirubin greater than or equal to 2.0 mg per dL (34.2 µmol per L).
• Severe renal impairment - creatinine clearance less than 30 ml per minute, calculated using the Cockcroft-Gault formula - or the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.
• Diabetes mellitus in a state of clinical and metabolic decompensation.
• Criteria for exclusion (dropout) from the study:
• Individual intolerance to drugs included in the treatment regimen.
• The patient's desire to stop participating in the study.

Where it is running

• The state institution N. N. Alexandrov National Cancer Centre of Belarus — Minsk, Minsk City, Belarus (enrolling)

Full record on ClinicalTrials.gov

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