NMIBCPhase 3NCT07424287
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
A Phase 3 study testing SHR-1501 for Injection, BCG for Injection and Epirubicin Hydrochloride for Injection in people with NMIBC, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive 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
- NMIBC
- What is being tested?
- SHR-1501 for Injection, BCG for Injection and Epirubicin Hydrochloride for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jul 2026to Jun 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-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive;
- 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;
- Not suitable for or unwilling to undergo radical cystectomy;
- 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 the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC;
- Those who have previously received immunostimulant therapy;
- 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
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhisong He, +86-010-83572600, wyj7074@sohu.com
Zhisong He
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School
Shanghai, Shanghai Municipality, 200120
Wei Xue, +86-021-58752345, uroxuewei@163.com
Wei Xue
About this study
Official title: A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).
- Conditions
- NMIBC
- Being tested
- SHR-1501 for Injection, BCG for Injection, Epirubicin Hydrochloride for Injection, Pirarubicin Hydrochloride for Injection, Gemcitabine Hydrochloride for Injection
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1501 for InjectionDrug
SHR-1501 for injection.
BCG for InjectionDrug
Bacillus calmette guerin (BCG) for injection.
Epirubicin Hydrochloride for InjectionDrug
Epirubicin hydrochloride for injection.
Pirarubicin Hydrochloride for InjectionDrug
Pirarubicin hydrochloride for injection.
Gemcitabine Hydrochloride for InjectionDrug
Gemcitabine hydrochloride for injection.
Hydroxycamptothecin for InjectionDrug
Hydroxycamptothecin for injection.
Mitomycin for InjectionDrug
Mitomycin for injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1501 + BCG Group | Experimental | SHR-1501, Bacillus Calmette Guerin (BCG). Receives: Drug: SHR-1501 for Injection; Drug: BCG for Injection |
| Investigator-selected Chemotherapy Group | Active comparator | Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin. Receives: Drug: Epirubicin Hydrochloride for Injection; Drug: Pirarubicin Hydrochloride for Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Hydroxycamptothecin for Injection; Drug: Mitomycin for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) assessed by Blinded Independent Central Review (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 (DFS) 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 (OS) is defined as the time from randomization to 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 posted20 Feb 2026
- Study start13 Jul 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies 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
- Model description
- A randomized, positive controlled, open-label study.
- Masking
- None (open label)
- Enrolment
- 236 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
- NCT07424287
- Sponsor's protocol ID
- SHR-1501-301
- Status last verified
- May 2026
- First submitted
- 13 Feb 2026
- Last updated
- 20 Jul 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)
- ClinicalTrials.gov ID
- NCT07424287
- Acronym / sponsor ID
- SHR-1501-301
- Conditions
- NMIBC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 20 Feb 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, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, positive controlled, open-label study.
| Arm | Type | Receives |
|---|---|---|
| SHR-1501 + BCG Group | Experimental | Drug: SHR-1501 for Injection, Drug: BCG for InjectionSHR-1501, Bacillus Calmette Guerin (BCG). |
| Investigator-selected Chemotherapy Group | Active comparator | Drug: Epirubicin Hydrochloride for Injection, Drug: Pirarubicin Hydrochloride for Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Hydroxycamptothecin for Injection, Drug: Mitomycin for InjectionEpirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin. |
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-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive;
- 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;
- Not suitable for or unwilling to undergo radical cystectomy;
Key exclusion criteria (6 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 the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC;
- Those who have previously received immunostimulant therapy;
- 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;
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 for InjectionSHR-1501 for injection. | Drug | SHR-1501 + BCG Group |
| BCG for InjectionBacillus calmette guerin (BCG) for injection. | Drug | SHR-1501 + BCG Group |
| Epirubicin Hydrochloride for InjectionEpirubicin hydrochloride for injection. | Drug | Investigator-selected Chemotherapy Group |
| Pirarubicin Hydrochloride for InjectionPirarubicin hydrochloride for injection. | Drug | Investigator-selected Chemotherapy Group |
| Gemcitabine Hydrochloride for InjectionGemcitabine hydrochloride for injection. | Drug | Investigator-selected Chemotherapy Group |
| Hydroxycamptothecin for InjectionHydroxycamptothecin for injection. | Drug | Investigator-selected Chemotherapy Group |
| Mitomycin for InjectionMitomycin for injection. | Drug | Investigator-selected Chemotherapy Group |
Primary outcome
Disease-Free Survival (DFS) assessed by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 5 years.
Disease free survival is defined as the time from randomization to date of DFS event assessed by BICR.
4 secondary outcomes
Disease-Free Survival (DFS) assessed by investigator
Time frame: Up to approximately 5 years.
Overall Survival (OS)
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 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Active, not recruitingPhase 3
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
Non-Muscle Invasive Bladder Neoplasms
RecruitingPhase 2
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
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RecruitingPhase 3
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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.
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 for Injection, BCG for Injection and Epirubicin Hydrochloride for Injection in people with NMIBC, 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 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: looking for participants now, as of the sponsor's last update on 20 Jul 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. 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 (+86-0518-82342973, 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 Blinded Independent Central Review (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 20 Jul 2026.