Actively Recruiting
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
Led by Research Institute for Physical Chemical Problems of the Belarusian State University · Updated on 2025-06-22
120
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
R
Research Institute for Physical Chemical Problems of the Belarusian State University
Lead Sponsor
N
N.N. Alexandrov National Cancer Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age from 18 to 75 years
- No severe concomitant diseases in the decompensation stage
- Written informed consent to participate in the study
- Ability to follow study instructions and comply with study design
You will not qualify if you...
- Pregnancy and lactation
- Presence of another primary malignant tumor except certain treated skin or cervical cancers more than 5 years ago
- Severe concomitant diseases in decompensation stage
- Family relationships with center staff
- Allergy to study drug components
- Refusal of proposed treatment
- Heart disease class III or IV or recent myocardial infarction within 6 months
- History of epileptic seizures
- Severe untreated diseases preventing protocol treatment
- Chronic liver or kidney failure
- Legal incapacity or inability to understand treatment consequences
- Socioeconomic or geographic factors limiting compliance
- History of alcohol or substance abuse within 2 years
- Participation in another clinical trial
- Acute tumor bleeding
- Low blood cell counts below specified thresholds
- Positive tests for HIV, hepatitis B or C
- Severe liver dysfunction with elevated liver enzymes or bilirubin
- Severe renal impairment with low creatinine clearance
- Uncontrolled diabetes mellitus
- Intolerance to treatment drugs
- Desire to withdraw from study
- Serious adverse events during study
- Non-compliance with study drug use
- Detection of a second malignant tumor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The state institution N. N. Alexandrov National Cancer Centre of Belarus
Minsk, Minsk City, Belarus, 223040
Actively Recruiting
Research Team
E
Eugen Grinyuk, Ph.D., Associate professor
CONTACT
P
Pavel Bychkovsky, Ph.D., Associate Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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