Bladder Perfusion of Plasma-Activated Saline for Bladder Cancer

NCT07272603 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: bks05
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Keywords

bladder; cancer; Intravesical Perfusion; plasma

Outcome Measures

Primary Outcomes (1)

• Change in Tumor Size

  The reduction in tumor volume will be quantitatively assessed by comparing the product of the largest perpendicular diameters of the target tumor lesion measured on high-resolution magnetic resonance imaging (MRI) scans before and after the intervention.

  Baseline (pre-treatment) and Day 7 (post-treatment).

Secondary Outcomes (1)

• Proportion of Tumor Cells Undergoing Apoptosis

  At the time of surgery (cystectomy), performed immediately following the 7-day intervention period.

Study Arms (1)

Plasma-Activated Saline Solution (PASS) Bladder Instillation

EXPERIMENTAL

This arm involves the intravesical instillation of the experimental intervention, Plasma-Activated Saline Solution (PASS), where 200 mL of the solution is administered into the bladder via a catheter every other day for 7 days, with a 1-hour dwell time, to evaluate its local efficacy in inducing tumor cell death and assess safety and tolerability.

Drug: Plasma-Activated Saline Solution (PASS) Bladder Instillation

Interventions

Plasma-Activated Saline Solution (PASS) Bladder Instillation DRUG

This intervention is distinguished by its unique mechanism of action, which utilizes physically-activated normal saline infused with reactive oxygen and nitrogen species (RONS) generated by non-thermal plasma, creating a potent yet transient cytotoxic solution that is administered locally.

Plasma-Activated Saline Solution (PASS) Bladder Instillation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Poor compliance, assessed as unlikely to complete the trial per protocol requirements.
• Any other condition deemed by the investigator to make the patient unsuitable for study participation.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Administration, Intravesical

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• benkang shi

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

weiqiang jing, PhD

CONTACT

86+053182166714; jiangxin98@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Urology Department

Model Details: This interventional study employs a single-arm, prospective, proof-of-concept model utilizing a within-subject control design, where each participant serves as their own baseline for comparison. The model leverages the pre-scheduled radical cystectomy as a definitive endpoint, allowing for a direct histological assessment of treatment effect. Efficacy is quantitatively measured by comparing pre- and post-treatment tumor volumes via MRI and analyzing the resected tissue for biomarkers of apoptosis, thereby providing a robust, paired analysis of the experimental intervention's biological impact within a short, controlled timeframe.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share