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

ConditionNon Muscle Invasive Bladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTianjin First Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Toripalimab combined with intravesical gemcitabineExperimental treatment 2 interventions

Trial outcomes

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin First Central Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: