Could a heart drug boost bladder cancer treatment?
NCT ID NCT07353294
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adding the blood pressure drug propranolol to standard immunotherapy and chemotherapy can help shrink bladder cancer that has spread to lymph nodes before surgery. The study enrolls 12 patients and primarily checks for safety and side effects. Researchers hope propranolol may overcome resistance in lymph node tumors by blocking stress signals.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- propranolol (a beta-blocker drug) combined with tislelizumab (an immunotherapy) and gemcitabine/cisplatin (chemotherapy)
- What this could lead to
- If successful, this could point toward a new treatment approach for bladder cancer that has spread to lymph nodes, potentially improving response rates.
- What could go wrong
- This is a very early phase 1 trial with only 12 participants, focused on safety. It is too small to prove effectiveness, and the combination may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily agrees to participate in the study, is able to provide written informed consent, and is willing to comply with study procedures and visit schedules. 2. Age ≥ 18 years at the time of consent; sex unrestricted. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. Histologically confirmed bladder urothelial carcinoma with clinical lymph node involvement (cT1-T4a, N1-N3, M0) based on the AJCC 8th edition. Mixed histology is permitted if the urothelial carcinoma component is ≥ 50%. 5. No antihypertensive medication used during screening, with resting systolic blood pressure between 110-140 mmHg measured under natural conditions. 6. Adequate organ function as demonstrated by laboratory results obtained within 14 days prior to enrollment: a. No administration of hematopoietic growth factors within 14 days prior to sample collection. i. Absolute neutrophil count ≥ 1.5 × 10⁹/L ii. Platelet count ≥ 90 × 10⁹/L iii. Hemoglobin ≥ 90 g/L b. INR or aPTT ≤ 1.5 × ULN c. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in patients with Gilbert syndrome or indirect hyperbilirubinemia) d. AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN e. Preoperative pulmonary function assessment indicating tolerance of major abdominal surgery. 7. Cisplatin-eligible patients, or cisplatin-ineligible patients who meet at least one of the following: * ECOG performance status \> 1 or Karnofsky 60-70% * Creatinine clearance \< 60 mL/min * Grade ≥ 2 hearing loss (NCI-CTCAE v5.0) * Grade ≥ 2 peripheral neuropathy (NCI-CTCAE v5.0) * New York Heart Association (NYHA) class III or above heart failure 8. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study and for ≥ 120 days after the last dose. Male participants must agree to use effective contraception during the study and for ≥ 120 days after the last dose. Exclusion Criteria: 1. Prior treatment with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors, or other T-cell co-stimulatory/checkpoint agents. 2. Systemic antineoplastic therapy or immunomodulatory therapy within 28 days prior to enrollment, including interferon, interleukin-2, or TNF-based agents. 3. Prior radiotherapy for bladder cancer. 4. Prior systemic anticancer therapy except: 1. Previous systemic chemotherapy completed ≥ 12 months before initiation of study treatment. 2. Intravesical chemotherapy or immunotherapy completed ≥ 7 days prior to initiation of study treatment. 5. Major surgery or significant trauma within 28 days prior to enrollment (vascular access placement and TURBT excluded). 6. Receipt of live attenuated vaccines within 28 days prior to enrollment. Inactivated influenza vaccination is allowed; intranasal influenza vaccine is not permitted. 7. Active autoimmune disease requiring systemic therapy, as judged by the investigator. 8. Long-term systemic corticosteroid therapy or other immunosuppressive medications judged to interfere with study treatment. 9. Uncontrolled systemic disease that may interfere with treatment, including: * Clinically relevant electrolyte abnormalities * Hypoalbuminemia * Interstitial lung disease or non-infectious pneumonitis * Uncontrolled diabetes, hypertension, or cardiovascular disease (including unstable angina, myocardial infarction, symptomatic heart failure, or medically managed ventricular arrhythmias within 6 months). 10. Chronic hepatitis B infection with HBV DNA ≥ 500 IU/mL (2,500 copies/mL). Patients with inactive HBsAg carrier status or viral suppression (HBV DNA \< 500 IU/mL) after antiviral therapy may be enrolled. HBV DNA testing is required if anti-HBc is positive. 11. Active hepatitis C infection. Patients who are HCV antibody negative, or HCV antibody positive but HCV RNA negative, are eligible. 12. History of immunodeficiency disorders (including HIV infection), congenital or acquired immune deficiency, or prior allogeneic stem cell transplantation or organ transplantation. 13. Known hypersensitivity to monoclonal antibodies, or known allergy to propranolol or other β-adrenergic receptor blockers. 14. Toxicities from previous therapies have not returned to baseline or stabilized, unless deemed not to pose a safety risk by the investigator (e.g., alopecia, neuropathy, specific laboratory abnormalities). 15. Contraindications to propranolol, including but not limited to: * Unstable angina * Decompensated heart failure * Symptomatic sinus bradycardia * Atrioventricular block * Severe asthma or bronchospasm 16. Current use of oral or intravenous β-blockers (e.g., atenolol, bisoprolol, carvedilol, metoprolol) that cannot be safely discontinued or transitioned. If previously used, a washout period of at least 14 days with medical reassessment is required before enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
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Other studies related to the condition(s) this trial covers.
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