Study of Prospidelong Gel Given Once Into the Abdomen to Treat Patients With Spread Gastric Cancer Phase 2-3, Randomized Open Trial to Assess Safety, Tolerability, and Effectiveness

What this Trial Is About

Researchers are evaluating the efficacy, tolerability, and safety of a single intraperitoneal dose of the investigational drug Prospidelong in patients with disseminated gastric cancer. This open-label, prospective, randomized clinical study plans to include 120 patients aged 18 to 75 years, divided evenly into two groups one receiving Prospidelong and the other serving as a comparison group. The study aims to assess survival and other health outcomes over an average of two years. Participants receive one dose of Prospidelong 4000 mg, equivalent to 2000 mg of prospidium chloride administered directly into the abdominal cavity after diagnostic surgery. The control group undergoes diagnostic surgery followed by systemic chemotherapy according to approved clinical protocols. After treatment, all patients continue with standard care and chemotherapy as specified by national guidelines. During the study, patients are monitored daily throughout their hospital stay and during follow-up visits. Assessments include physical exams, blood tests, urine analyses, ultrasound or CT scans, and evaluation of performance status using the ECOG scale at multiple time points up to two years post-surgery. Researchers track safety, treatment tolerability, and survival as primary outcomes, with imaging and laboratory tests as secondary measures.

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