Non Muscle Invasive Bladder CancerPhase 2NCT07808216
Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy for High-Risk Non-Muscle-Invasive Bladder Cancer After TURBT
A Phase 2 study testing Toripalimab (JS001 ) and Gemcitabine (GEM) in people with Non Muscle Invasive Bladder Cancer, run by Tianjin First Central Hospital.
Trial summary
This is a prospective, open-label, single-center, single-arm phase II clinical study to evaluate the efficacy and safety of toripalimab combined with intravesical gemcitabine as adjuvant therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- What is being tested?
- Toripalimab (JS001 ) and Gemcitabine (GEM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2031
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high-risk non-muscle-invasive urothelial carcinoma after TURBT who have not received prior BCG therapy.
- Male or female, aged 18 to 85 years.
- Life expectancy of more than 12 weeks.
- ECOG performance status of 0 to 2.
- No prior immunotherapy or other systemic therapy for the disease under study.
- Adequate organ function.
- Willing and able to comply with the study procedures and follow-up schedule.
- Ability to understand and willingness to voluntarily sign the informed consent form (ICF).
Who cannot join
- Receipt of a live attenuated vaccine within 4 weeks prior to enrollment, or planned receipt during the study period.
- Active, known, or suspected autoimmune disease.
- Known history of primary immunodeficiency.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Pregnant or breastfeeding women.
- Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
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- Uncontrolled comorbidities, including but not limited to the following:
- HIV infection (HIV antibody positive).
- Active or clinically uncontrolled severe infection.
- Evidence of severe or uncontrolled systemic disease, including but not limited to severe psychiatric or neurological disorders, epilepsy or dementia; unstable or uncompensated respiratory, cardiovascular, hepatic, or renal disease; or uncontrolled hypertension (≥ CTCAE grade 2 despite medical therapy).
- Active bleeding, newly diagnosed thromboembolic disease requiring therapeutic-dose anticoagulation, or bleeding diathesis.
- Known hypersensitivity to the investigational drugs (toripalimab or gemcitabine).
- Any other condition judged by the investigator to render the patient unsuitable for enrollment.
- Concurrent participation in another clinical study.
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: A Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy After Transurethral Resection of Bladder Tumor (TURBT) in Patients With High-Risk Urothelial Carcinoma
This is a prospective, open-label, single-center, single-arm phase II clinical study to evaluate the efficacy and safety of toripalimab combined with intravesical gemcitabine as adjuvant therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). Patients with high-risk NMIBC are planned to be enrolled. Treatment consists of one immediate intravesical instillation of gemcitabine after TURBT, followed by induction intravesical chemotherapy with gemcitabine for 4-8 instillations, and then maintenance treatment with toripalimab combined with intravesical gemcitabine 2000 mg once monthly for 12 instillations.
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- Toripalimab (JS001 ), Gemcitabine (GEM)
- Keywords
- Urinary Bladder Neoplasms
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab (JS001 )Drug
Toripalimab 240 mg administered intravenously once every 3 weeks (Q3W), starting 4-8 weeks after surgery (after induction intravesical chemotherapy), given concurrently with maintenance intravesical gemcitabine, for 17 cycles or until disease progression, death, or unacceptable toxicity.
Gemcitabine (GEM)Drug
Gemcitabine 2000 mg administered by intravesical instillation, in three phases: (1) one immediate instillation (SI) after TURBT; (2) induction phase: once weekly for 4-8 instillations; (3) maintenance phase: once monthly for 12 instillations, given concurrently with toripalimab, until disease progression, death, or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab combined with intravesical gemcitabine | Experimental | All enrolled patients receive toripalimab combined with intravesical gemcitabine: one immediate intravesical instillation of gemcitabine after TURBT, followed by 4-8 once-weekly induction instillations, then toripalimab (240 mg IV every 3 weeks for 17 cycles) combined with maintenance intravesical gemcitabine (2000 mg once monthly for 12 instillations), until disease progression, death, or unacceptable toxicity. Receives: Drug: Toripalimab (JS001 ); Drug: Gemcitabine (GEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (CR) Rate at 3 Months
Measured: 3 months after the first dose of study treatment.
Secondary outcomes (2)
Incidence of Adverse Events
Measured: From the first dose of study treatment until 1 month after the last dose (end of safety follow-up), or until the start of a new anti-cancer therapy, whichever occurs first.
Overall Survival (OS)
Measured: From enrollment to death from any cause, assessed 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 posted8 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Liu, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808216
- Sponsor's protocol ID
- UBC-IIT-JS001-A02
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy After Transurethral Resection of Bladder Tumor (TURBT) in Patients With High-Risk Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07808216
- Acronym / sponsor ID
- UBC-IIT-JS001-A02
- Conditions
- Non Muscle Invasive Bladder Cancer
- Keywords
- Urinary Bladder Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 8 Sep 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 prospective, open-label, single-center, single-arm phase II clinical study to evaluate the efficacy and safety of toripalimab combined with intravesical gemcitabine as adjuvant therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). Patients with high-risk NMIBC are planned to be enrolled. Treatment consists of one immediate intravesical instillation of gemcitabine after TURBT, followed by induction intravesical chemotherapy with gemcitabine for 4-8 instillations, and then maintenance treatment with toripalimab combined with intravesical gemcitabine 2000 mg once monthly for 12 instillations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab combined with intravesical gemcitabine | Experimental | Drug: Toripalimab (JS001 ), Drug: Gemcitabine (GEM)All enrolled patients receive toripalimab combined with intravesical gemcitabine: one immediate intravesical instillation of gemcitabine after TURBT, followed by 4-8 once-weekly induction instillations, then toripalimab (240 mg IV every 3 weeks for 17 cycles) combined with maintenance intravesical gemcitabine (2000 mg once monthly for 12 instillations), until disease progression, death, or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with high-risk non-muscle-invasive urothelial carcinoma after TURBT who have not received prior BCG therapy.
- Male or female, aged 18 to 85 years.
- Life expectancy of more than 12 weeks.
- ECOG performance status of 0 to 2.
- No prior immunotherapy or other systemic therapy for the disease under study.
Key exclusion criteria (14 listed)
- Receipt of a live attenuated vaccine within 4 weeks prior to enrollment, or planned receipt during the study period.
- Active, known, or suspected autoimmune disease.
- Known history of primary immunodeficiency.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Toripalimab (JS001 )Toripalimab 240 mg administered intravenously once every 3 weeks (Q3W), starting 4-8 weeks after surgery (after induction intravesical chemotherapy), given concurrently with maintenance intravesical gemcitabine, for 17 cycles or until disease progression, death, or unacceptable toxicity. | Drug | Toripalimab combined with intravesical gemcitabine |
| Gemcitabine (GEM)Gemcitabine 2000 mg administered by intravesical instillation, in three phases: (1) one immediate instillation (SI) after TURBT; (2) induction phase: once weekly for 4-8 instillations; (3) maintenance phase: once monthly for 12 instillations, given concurrently with toripalimab, until disease progression, death, or unacceptable toxicity. | Drug | Toripalimab combined with intravesical gemcitabine |
Primary outcome
Pathologic Complete Response (CR) Rate at 3 Months
Time frame: 3 months after the first dose of study treatment.
2 secondary outcomes
Incidence of Adverse Events
Time frame: From the first dose of study treatment until 1 month after the last dose (end of safety follow-up), or until the start of a new anti-cancer therapy, whichever occurs first.
Overall Survival (OS)
Time frame: From enrollment to death from any cause, assessed 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: 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab (JS001 ) and Gemcitabine (GEM) in people with Non Muscle Invasive Bladder Cancer, run by Tianjin First Central Hospital.
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 8 inclusion and 14 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 8 Sep 2026. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Qian Liu (86-18622051376, simonlq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (CR) Rate at 3 Months (time frame: 3 months after the first dose of study 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 8 Sep 2026.