A Prospective, Multicenter, Single-Arm, Phase Ⅱ, Exploratory Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.

NCT06630871 Phase 2 NOT_YET_RECRUITING

This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+.

Details

Lead sponsor	Fujian Medical University Union Hospital
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	40
Start date	2024-10
Completion	2028-10

Conditions

• NMIBC

Interventions

• Distitamab Vedotin in combination with Tislelizumab

Primary outcomes

• 1-year Event-Free Survival rate — From date of randomization until the date of any event occurrence, whichever came first，assessed up to 12 months
  The possibility of patients have not experienced any events for at least 12 months after receiving treatment, including death, disease progression, switch to chemotherapy, addition of other treatments, fatal or intolerable side effects, etc

Countries

China