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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings