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Not yet recruitingNCT07808216Updated Sep 8, 2026

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

A Phase 2 interventional study of Toripalimab (JS001 ) and Gemcitabine (GEM) in Non Muscle Invasive Bladder Cancer, sponsored by Tianjin First Central Hospital. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Tianjin First Central Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non Muscle Invasive Bladder Cancer

Keywords

  • Urinary Bladder Neoplasms
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • 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 ) · Drug: Gemcitabine (GEM)

Interventions

  • DrugToripalimab (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.

  • DrugGemcitabine (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.

05

What researchers measure

Primary outcomes

  1. Pathologic Complete Response (CR) Rate at 3 Months

    Time frame: 3 months after the first dose of study treatment.

Secondary outcomes

  1. 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.

  2. Overall Survival (OS)

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07808216
Lead sponsor
Tianjin First Central Hospital
Responsible party
Qian Liu (Professor, Tianjin First Central Hospital) — Principal investigator
First posted
Sep 8, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2028 (estimated)
Completion
Oct 1, 2031 (estimated)
Last update
Sep 8, 2026

Study contacts

Qian Liu
Contact
simonlq@163.com
86-18622051376

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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