A Phase 2/3 interventional study of Prospidelong and chemotherapy in Gastric Cancer With Peritoneal Dissemination, sponsored by Research Institute for Physical Chemical Problems of the Belarusian State University. Recruiting at 1 site in Belarus. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by Research Institute for Physical Chemical Problems of the Belarusian State University · Phase 2/3, Interventional, and Treatment
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.
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.
Inclusion - preliminary interview with the patient and signing of informed consent.
Informed consent is the free and voluntary expression of the subject's desire to participate in a specific study after receiving information about all aspects of this study that are significant for the subject's decision to participate, and in the case of minors and incapacitated subjects, the permission or consent of their legal representatives to include such subjects into the study. Informed consent is documented by signing and dating the informed consent form.
Signed and dated informed consent must be obtained from each patient or, if the patient is unable to make an informed decision due to health reasons, from the patient's spouse/close relative (close relatives include parents, adult children, siblings, grandparents) , grandchildren), and the patient's signed informed consent to participate in the study must additionally be obtained as soon as his health condition allows it.
Before signing informed consent, all potential participants should be informed of the nature and purpose of the study, including possible risks and unwanted effects, and given sufficient time to read and understand the information presented. The researcher should answer any questions that arise. The researcher must also sign an informed consent form. After signing, one copy of the informed consent is given to the patient (the patient\'s spouse/close relative) and one copy remains at the center for storage in the Researcher\'s file.
Preparatory period - includes screening patients for compliance with inclusion and exclusion criteria, determining the initial condition of the patient. During screening, a medical history will be taken and the patient\'s date of birth, age and gender will be recorded. When collecting anamnesis, you should clarify data on concomitant diseases and medications used to treat the main and concomitant diseases, drug intolerance, and allergic reactions.
During screening, the patient\'s medications and procedures performed over the past 30 days must also be recorded. Registration of concomitant therapy for the main and concomitant diseases is carried out at each visit. All changes in the treatment regimen for the underlying disease (changes in the standard therapy received by the patient as part of rehabilitation treatment in the postoperative period and during systemic chemotherapy drug treatment after discharge from the hospital) and in the treatment of concomitant diseases are recorded: changes in the dose and frequency of administration of previously prescribed drugs, prescription new drugs.
After signing the informed consent and screening, patients undergo a general clinical examination 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).
The scope of research before treatment includes:
According to indications: fibrocolonoscopy, laparoscopy, irrigoscopy, angiography, MRI, scintigraphy of skeletal bones, computed tomography - for no more than 7 days before inclusion.
Preliminary selection. Based on the results of the preoperative examination, a preliminary selection of patients with resectable gastric cancer is carried out.
The final selection is carried out intraoperatively based on the results of the abdominal cavity revision (see above). Patients with the presence of peritoneal dissemination, confirmed by morphological examination, are selected. The scope of surgical intervention will be limited to biopsy of areas of the peritoneum with disseminates. Randomization of patients will be carried out by an employee of the department of automated control systems of the Republican Scientific and Practical Center for OMR named after. N.N. Aleksandrova using the "Randomization" software based on random number generation. The result of randomization will be confirmed by protocols of the established form. During randomization, patients will be divided into the following groups: main (experimental) and control group. Patients of the main group, after placing a control drainage in the abdominal cavity, will undergo intraperitoneal application of the study drug Prospidelong at a dose of 4000 mg. Patients in the control group did not undergo intraperitoneal administration of Prospidelong.
Individual registration cards (IRCs) are created for patients included in a clinical trial.
Recruitment of patients into the groups will be done using a sequential enrollment method. Patients excluded from the study for any reason will not be replaced.
Treatment period Intraperitoneal use of the study drug Prospidelong will be a single dose. Subsequent treatment of patients will be carried out 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).
The scope of research in the study groups in the postoperative period will include:
Deviations in the timing of ultrasound and CT of the abdominal cavity are allowed if progression of the tumor process is suspected (CT is performed only if progression of the disease is suspected and other research methods are not informative).
After using the study drug Prospidelong, the researcher evaluates the immediate and immediate results and enters the evaluation data into the CRF. The assessment of the necessary parameters is carried out in the hospital after surgery, as well as during subsequent visits to the patient for a follow-up examination within the specified time frame.
At each study visit, the patient\'s complaints will be assessed by the study physician.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Research Institute for Physical Chemical Problems of the Belarusian State University is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Non-inclusion criteria based on survey data:
Criteria for exclusion (dropout) from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
after diagnostic laparotomy/laparoscopy, a single intraperitoneal administration of the study drug Prospidelong, produced by UNITEHPROM BSU, Republic of Belarus, further in accordance with the protocols of the Ministry of Health of the Republic of Belarus for the treatment of patients with the corresponding pathology, systemic chemotherapy in accordance with the clinical protocol "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).
Drug: Prospidelong · Procedure: chemotherapy
after 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 the degree of prevalence of the tumor process corresponding to sT1-4N0-3M1.
Procedure: chemotherapy
Prospidium 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.
after 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.
Time frame: through study completion, an average of 2 years
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
Time frame: through study completion, an average of 2 years
detailed general blood test
Blood samples will be collected for the analysis of hemoglobin, erythrocytes, leukocytes, segmented neutrophils, platelets level
Time frame: through study completion, an average of 2 years
blood chemistry
Blood samples will be collected for the analysis of total protein, creatinine, urea, bilirubin, AST, ALT level
Time frame: through study completion, an average of 2 years
Plan to share: No
Started Jun 2025 (actual). Primary completion is estimated for Dec 2025, 6 months after the start.
Of 26 phase 2/3 interventional studies under Stomach Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 52. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
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Research Institute for Physical Chemical Problems of the Belarusian State University