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NCT06232434: ИНТЕЛОН-02
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
Phase 2/Phase 3 trial testing Prospidelong in Gastric Cancer With Peritoneal Dissemination in 120 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | Research Institute for Physical Chemical Problems of the Belarusian State University |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 20 June 2025 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across Belarus |
Drugs / interventions tested
- Prospidelong — full drug profile →
- chemotherapy (chemotherapy) — full drug profile →
Conditions studied
- Gastric Cancer With Peritoneal Dissemination — all drugs for Gastric Cancer With Peritoneal Dissemination →
Sponsor
Research Institute for Physical Chemical Problems of the Belarusian State University
Who can join
Adults 18 to 75, any sex, with Gastric Cancer With Peritoneal Dissemination. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
increased survival
Time frame: through study completion, an average of 2 years
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 (
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06232434
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06232434 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Research Institute for Physical Chemical Problems of the Belarusian State University
- Last refreshed: 20 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06232434.
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