Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy for High-Risk Non-Muscle-Invasive Bladder Cancer After TURBT

September 7, 2026 updated by: Qian Liu, Tianjin First Central Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

  • Uncontrolled comorbidities, including but not limited to the following:

    1. HIV infection (HIV antibody positive).
    2. Active or clinically uncontrolled severe infection.
    3. 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).
    4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toripalimab combined with intravesical gemcitabine
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.
Drug: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic Complete Response (CR) Rate at 3 Months
Time Frame: 3 months after the first dose of study treatment.
3 months after the first dose of study treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
From enrollment to death from any cause, assessed up to approximately 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin First Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBC-IIT-JS001-A02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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