Bladder Perfusion of Plasma-Activated Saline for Bladder Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University
About this trial
This preliminary clinical study evaluates the safety and initial efficacy of a novel therapy called Plasma-Activated Saline Solution (PASS) for bladder cancer patients. The study involves a one-week course of PASS administered via bladder infusion in five pre-surgical patients, using imaging and pathology analyses to assess tumor shrinkage and cancer cell death, while closely monitoring for any adverse reactions to explore the therapy's future potential.
Eligibility criteria
Qualifiers
Patients with a pathological diagnosis of bladder cancer.
Patients scheduled for radical cystectomy, with at least one measurable tumor lesion ≥10 mm in diameter.
Age between 18 and 75 years.
Treatment-naïve patients who have not received any prior therapy for bladder cancer.
Disqualifiers
Presence of severe comorbidities, including but not limited to cardiac disease, severe hepatic or renal insufficiency, uncontrolled hypertension, or diabetes.
Active urinary tract infection or a functional bladder capacity of less than 200 mL.
History of other malignancies.
Pregnancy or lactation.
Trial design
Treatments tested in this trial
- Plasma-Activated Saline Solution (PASS) Bladder Instillation
Treatment groups
5 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov