Bladder (Urothelial, Transitional Cell) CancerEarly Phase 1NCT07272603
Bladder Perfusion of Plasma-Activated Saline for Bladder Cancer
A Early Phase 1 study testing Plasma-Activated Saline Solution (PASS) Bladder Instillation in people with Bladder (Urothelial, Transitional Cell) Cancer, run by Qilu Hospital of Shandong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer
- What is being tested?
- Plasma-Activated Saline Solution (PASS) Bladder Instillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preliminary Clinical Study Evaluating the Therapeutic Response and Safety of Intravesical Perfusion With Plasma-Activated Saline Solution in Patients With Bladder Cancer
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.
Read the detailed description
This study is a prospective, proof-of-concept clinical trial investigating a novel local therapy for bladder cancer. The intervention involves the use of Plasma-Activated Saline Solution (PASS), a liquid infused with reactive oxygen and nitrogen species (RONS) created by exposing standard saline to cold atmospheric plasma. The goal is to leverage the potential of these activated substances to selectively target and kill cancer cells while minimizing damage to healthy bladder tissue.
The study will enroll a small cohort of five adult patients with confirmed bladder cancer who are already scheduled for a radical cystectomy (surgical removal of the bladder). This design allows for a direct assessment of the treatment's effect on the tumor within a short, controlled timeframe before surgery. Participants will receive intravesical (into the bladder) instillations of PASS every other day for one week, with each instillation retained for approximately one hour.
The primary objectives are twofold. First, to evaluate the treatment's efficacy, researchers will quantitatively measure the reduction in tumor volume using MRI scans conducted before and after the 7-day treatment period. Additionally, the surgically removed bladder tissue will be analyzed in the laboratory using immunohistochemistry to look for biological evidence of cancer cell death (apoptosis). Second, the study will rigorously assess safety and tolerability. This includes monitoring for severe, procedure-related adverse events and systematically tracking patient-reported symptoms like urinary pain and urgency using standardized diaries and scales.
As an initial exploratory investigation, this study is not designed to prove definitive clinical efficacy but to gather crucial first-in-human data on the biological activity and safety profile of PASS. The findings will determine whether this innovative approach warrants further development in larger clinical trials. The study will be conducted under strict ethical guidelines with close safety monitoring and full informed consent from all participants.
- Being tested
- Plasma-Activated Saline Solution (PASS) Bladder Instillation
- Keywords
- bladder, cancer, Intravesical Perfusion, plasma
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma-Activated Saline Solution (PASS) Bladder InstillationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Plasma-Activated Saline Solution (PASS) Bladder Instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-treatment) and Day 7 (post-treatment).
Secondary outcomes (1)
Proportion of Tumor Cells Undergoing Apoptosis
The biological effect on tumor cells will be evaluated through immunohistochemical analysis of biopsy specimens obtained during the post-treatment cystectomy, specifically measuring the percentage of tumor cells testing positive for TUNEL staining, which indicates programmed cell death (apoptosis).
Measured: At the time of surgery (cystectomy), performed immediately following the 7-day intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benkang Shi, Qilu Hospital of Shandong University
- Investigators
- benkang shi, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272603
- Sponsor's protocol ID
- bks05
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Clinical Study Evaluating the Therapeutic Response and Safety of Intravesical Perfusion With Plasma-Activated Saline Solution in Patients With Bladder Cancer
- ClinicalTrials.gov ID
- NCT07272603
- Acronym / sponsor ID
- bks05
- Keywords
- bladder, cancer, Intravesical Perfusion, plasma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, proof-of-concept clinical trial investigating a novel local therapy for bladder cancer. The intervention involves the use of Plasma-Activated Saline Solution (PASS), a liquid infused with reactive oxygen and nitrogen species (RONS) created by exposing standard saline to cold atmospheric plasma. The goal is to leverage the potential of these activated substances to selectively target and kill cancer cells while minimizing damage to healthy bladder tissue.
The study will enroll a small cohort of five adult patients with confirmed bladder cancer who are already scheduled for a radical cystectomy (surgical removal of the bladder). This design allows for a direct assessment of the treatment's effect on the tumor within a short, controlled timeframe before surgery. Participants will receive intravesical (into the bladder) instillations of PASS every other day for one week, with each instillation retained for approximately one hour.
The primary objectives are twofold. First, to evaluate the treatment's efficacy, researchers will quantitatively measure the reduction in tumor volume using MRI scans conducted before and after the 7-day treatment period. Additionally, the surgically removed bladder tissue will be analyzed in the laboratory using immunohistochemistry to look for biological evidence of cancer cell death (apoptosis). Second, the study will rigorously assess safety and tolerability. This includes monitoring for severe, procedure-related adverse events and systematically tracking patient-reported symptoms like urinary pain and urgency using standardized diaries and scales.
As an initial exploratory investigation, this study is not designed to prove definitive clinical efficacy but to gather crucial first-in-human data on the biological activity and safety profile of PASS. The findings will determine whether this innovative approach warrants further development in larger clinical trials. The study will be conducted under strict ethical guidelines with close safety monitoring and full informed consent from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Plasma-Activated Saline Solution (PASS) Bladder Instillation | Experimental | Drug: Plasma-Activated Saline Solution (PASS) Bladder InstillationThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma-Activated Saline Solution (PASS) Bladder InstillationThis 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. | Drug | Plasma-Activated Saline Solution (PASS) Bladder Instillation |
Primary outcome
Change in Tumor Size
Time frame: Baseline (pre-treatment) and Day 7 (post-treatment).
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.
1 secondary outcome
Proportion of Tumor Cells Undergoing Apoptosis
Time frame: At the time of surgery (cystectomy), performed immediately following the 7-day intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
benkang shi principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Plasma-Activated Saline Solution (PASS) Bladder Instillation in people with Bladder (Urothelial, Transitional Cell) Cancer, run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact weiqiang jing, PhD (86+053182166714, jiangxin98@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tumor Size (time frame: Baseline (pre-treatment) and Day 7 (post-treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.