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

NCT07808216 | Not Yet Recruiting Phase 2

• 1 other identifier: UBC-IIT-JS001-A02
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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 (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

Keywords

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (CR) Rate at 3 Months

  3 months after the first dose of study treatment.

Secondary Outcomes (2)

• Incidence of Adverse Events

  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)

  From enrollment to death from any cause, assessed up to approximately 5 years.

Study Arms (1)

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.

Drug: Toripalimab (JS001 ); Drug: Gemcitabine (GEM)

Interventions

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.

Toripalimab combined with intravesical gemcitabine

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.

Toripalimab combined with intravesical gemcitabine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Tianjin First Central Hospital: lead

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Interventions

toripalimab; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Qian Liu

CONTACT

86-18622051376; simonlq@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 8, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2031
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share