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

NCT06232434 | Recruiting Phase 2

• 1 other identifier: ИНТЕЛОН-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer With Peritoneal Dissemination

Keywords

gastric cancer with peritoneal dissemination; prospidin; dextran phosphate

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 2 years

Secondary Outcomes (3)

• Ultrasound and/or computed tomography of the abdominal cavity (if necessary)

  through study completion, an average of 2 years

• detailed general blood test

  through study completion, an average of 2 years

• blood chemistry

  through study completion, an average of 2 years

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Comparison group

PLACEBO COMPARATOR

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

Interventions

Prospidelong DRUG

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.

Experimental arm

chemotherapy PROCEDURE

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

Comparison group; Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Acute bleeding from the tumor.

Sponsors & Collaborators

• Research Institute for Physical Chemical Problems of the Belarusian State University: lead
• N.N. Alexandrov National Cancer Centre: collaborator
• Unitary Enterprise UNITEHPROM BSU: collaborator

Study Sites (1)

The state institution N. N. Alexandrov National Cancer Centre of Belarus

Minsk, Minsk City, 223040, Belarus

RECRUITING

Related Publications (1)

• Solomevich SO, Bychkovsky PM, Yurkshtovich TL, Golub NV, Mirchuk PY, Revtovich MY, Shmak AI. Biodegradable pH-sensitive prospidine-loaded dextran phosphate based hydrogels for local tumor therapy. Carbohydr Polym. 2019 Dec 15;226:115308. doi: 10.1016/j.carbpol.2019.115308. Epub 2019 Sep 9.

  PMID: 31582057 BACKGROUND

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Eugen Grinyuk, Ph.D., Associate professor

CONTACT

+375 17 209-52-54; hryniuk@bsu.by

Pavel Bychkovsky, Ph.D., Associate Professor

CONTACT

+375 17 209-58-40; bychkovsky@tut.by

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 30, 2024
• Study Start: June 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)