DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

June 1, 2030

Study Completion Date

December 1, 2030

Conditions
Bladder (Urothelial, Transitional Cell) CancerNMIBC
Interventions
DRUG

Active Comparator: BCG induction and maintenance

"Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer~Other Names:~BCG"

DRUG

DV + BCG induction and maintenance

"Drug: Disitamab vedotin(RC48) •An antibody-drug conjugates (ADCs) targeting HER2, has been approved in China for chemotherapy-refractory advanced UC with HER2-expression.~Other Names:~• RC48, DV~Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer~Other Names:~BCG"

Trial Locations (1)

200230

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Fujian Cancer Hospital

OTHER_GOV

collaborator

Tenth People's Hospital of Tongji Univeristy

UNKNOWN

collaborator

Ningbo Medical Center Li Huili Hospital

UNKNOWN

lead

Fudan University

OTHER