Papillary-Only Non-muscle-invasive Bladder CancerPhase 3NiBladder 2NCT07726992
A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC
A Phase 3 study testing SHR-1501+BCG in people with Papillary-Only Non-muscle-invasive Bladder Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary-Only Non-muscle-invasive Bladder Cancer
- What is being tested?
- SHR-1501+BCG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 2 sitesChina
- Study dates
- 25 Aug 2026to Aug 2030
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged at least 18 years, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
- No previous BCG therapy;
- 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;
- Sufficient hematology and organ function;
Who cannot join
- Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+).
- 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;
- Those who have previously received immunostimulant therapy or immune checkpoint inhibitors;
- Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
- Those who plan to undergo radical (partial) cystectomy during the study;
- 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;
- Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100036
Xu Zhang
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Kai Yao
About this study
Official title: A Multicenter, Randomized, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC)
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)
- Being tested
- SHR-1501+BCG, Placebo +BCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1501+BCGDrug
SHR-1501+BCG
Placebo +BCGDrug
Placebo +BCG
| Study group | Role | What they receive |
|---|---|---|
| SHR-1501+BCG | Experimental | Not described Receives: Drug: SHR-1501+BCG |
| Placebo +BCG | Placebo comparator | Not described Receives: Drug: Placebo +BCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR.
Measured: Up to approximately 5 years
Secondary outcomes (4)
Disease-Free Survival (DFS) assessed by investigator: Disease-free survival is defined as the time from randomization to date of DFS event assessed by investigator.
Measured: Up to approximately 5 years
Overall Survival (OS): Overall Survival defined as the time from randomization to the date of death from any cause.
Measured: Up to approximately 5 years.
Number of adverse events (AEs) as assessed by CTCAE v6.0.
Measured: Up to approximately 5 years.
Number of serious adverse events (SAEs) as assessed by CTCAE v6.0.
Measured: Up to approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start25 Aug 2026
- Primary completionDec 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary-Only Non-muscle-invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726992
- Sponsor's protocol ID
- SHR-1501-302
- Acronym
- NiBladder 2
- Status last verified
- Feb 2026
- First submitted
- 21 Jul 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT07726992
- Acronym / sponsor ID
- NiBladder 2 / SHR-1501-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 27 Jul 2026 (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 is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1501+BCG | Experimental | Drug: SHR-1501+BCG |
| Placebo +BCG | Placebo comparator | Drug: Placebo +BCG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged at least 18 years, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
- No previous BCG therapy;
- 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;
Key exclusion criteria (7 listed)
- Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+).
- 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;
- Those who have previously received immunostimulant therapy or immune checkpoint inhibitors;
- Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
- Those who plan to undergo radical (partial) cystectomy during the study;
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 |
|---|---|---|
| SHR-1501+BCGSHR-1501+BCG | Drug | SHR-1501+BCG |
| Placebo +BCGPlacebo +BCG | Drug | Placebo +BCG |
Primary outcome
Disease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR.
Time frame: Up to approximately 5 years
4 secondary outcomes
Disease-Free Survival (DFS) assessed by investigator: Disease-free survival is defined as the time from randomization to date of DFS event assessed by investigator.
Time frame: Up to approximately 5 years
Overall Survival (OS): Overall Survival defined as the time from randomization to the date of death from any cause.
Time frame: Up to approximately 5 years.
Number of adverse events (AEs) as assessed by CTCAE v6.0.
Time frame: Up to approximately 5 years.
Number of serious adverse events (SAEs) as assessed by CTCAE v6.0.
Time frame: Up to approximately 5 years.
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 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Papillary-Only Non-muscle-invasive Bladder Cancer
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A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
NMIBC
RecruitingPhase 2
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-1501+BCG in people with Papillary-Only Non-muscle-invasive Bladder Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wenliang Wang (0518-82342973, wenliang.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR. (time frame: Up to approximately 5 years). 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 8 Sep 2026.