A 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.

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2028

Conditions
NMIBC
Interventions
DRUG

Distitamab Vedotin in combination with Tislelizumab

On the day after the initial TURBt procedure, use trastuzumab (200mg)+ Distitamab Vedotin (120mg \[≤ 60Kg\] or 2.0mg/Kg \[\>60Kg\]) every 3 weeks (Q3W). Simultaneously arrange for the patient to complete a second TURBt within 6 weeks, and continue to use 3 courses of Trastuzumab+Vediximab (Q3W) after surgery until the endpoint of 3-year follow-up

Trial Locations (1)

350001

Fujian Medical University Union Hospital, Fuzhou

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BeiGene

INDUSTRY

collaborator

RemeGen Co., Ltd.

INDUSTRY

lead

Fujian Medical University Union Hospital

OTHER

NCT06630871 - A 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. | Biotech Hunter | Biotech Hunter