Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer

This is a multicenter, prospective, open-label, Phase II, four-arm parallel study evaluating the efficacy and safety of different sensitization strategies combined with disitamab vedotin and toripalimab in patients with HER2-positive muscle-invasive urothelial carcinoma of the bladder (MIBC). Eligible patients with cT2-4aN0M0 HER2-positive urothelial carcinoma of the bladder will receive neoadjuvant disitamab vedotin plus toripalimab in combination with one of four sensitizing agents: sitagliptin, tazemetostat, tafolecimab, or ursodeoxycholic acid. After six cycles of neoadjuvant treatment,

Trial Details

NCT ID

NCT07717242

Phase

PHASE2

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Status

RECRUITING

Cancer Type

Urothelial Carcinoma Bladder Cancer

Interventions

Disitamab vedotin
Toripalimab
Sitagliptin
Zeprumetostat
Tafolecimab
Ursodeoxycholic Acid

Locations (sample)

Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

Voluntarily participate in this study, provide written informed consent, and be able to understand and agree to comply with the study requirements …
Age ≥18 years on the date of signing the informed consent form.
Histologically confirmed and radiologically assessed cT2-T4aN0M0 urothelial carcinoma of the bladder according to the American Joint Committee on C…
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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