Can an experimental immunotherapy boost the power of standard bladder cancer treatment?
NCT ID NCT07726992
First seen Jul 27, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This phase 3 trial is testing whether adding an experimental drug called SHR-1501 to the standard BCG therapy can improve outcomes for people with a high-risk form of bladder cancer that has not spread into the muscle wall. Participants must have had all visible tumors removed before starting treatment. The study compares the combination against BCG plus a placebo to see if it extends the time before the cancer returns.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental immunotherapy drug called SHR-1501 combined with a standard bladder cancer treatment (BCG)
- What this could lead to
- If successful, this combination could offer a more effective treatment option for people with high-risk bladder cancer, potentially reducing the chance of the cancer coming back.
- What could go wrong
- This is an early-phase trial, so the benefits are not yet proven. Adding a new drug may also increase side effects, and the results may not apply to all patients.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 750 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2026
- Expected to finish
-
Aug 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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. Aged at least 18 years, gender is not limited; 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; 3. Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); 4. No previous BCG therapy; 5. Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue; 6. Sufficient hematology and organ function; Exclusion Criteria: 1. Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+). 2. Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization; 3. Those who have previously received immunostimulant therapy or immune checkpoint inhibitors; 4. Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator; 5. Those who plan to undergo radical (partial) cystectomy during the study; 6. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration; 7. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization;
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for High-risk papillary-only non-muscle-invasive bladder cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
-
The First Medical Center of the Chinese People's Liberation Army General Hospital
RECRUITINGBeijing, Beijing Municipality, 100036, China