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A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer

NCT07279597 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-19

No results posted yet for this study

Summary

This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+/2+/3+) status. Treatment Flow: Post maximal Transurethral Resection of Bladder Tumor (TURBT); 2 cycles of Gemcitabine + Cisplatin chemotherapy; 4 cycles of RC48-ADC + Toripalimab targeted therapy; Radiotherapy (60-64 Gy) with concurrent Toripalimab treatment; Continue with 6 cycles of RC48-ADC + Toripalimab after radiotherapy completion; Patients achieving CR will receive maintenance therapy with Toripalimab for 1 year.

Conditions

  • Muscle-invasive Bladder Urothelial Carcinoma

Interventions

DRUG

RC48-ADC + Toripalimab

Treatment Flow: Post maximal Transurethral Resection of Bladder Tumor (TURBT); 2 cycles of Gemcitabine + Cisplatin chemotherapy; 4 cycles of RC48-ADC + Toripalimab targeted therapy; Radiotherapy (60-64 Gy) with concurrent Toripalimab treatment; Continue with 6 cycles of RC48-ADC + Toripalimab after radiotherapy completion; Patients achieving CR will receive maintenance therapy with Toripalimab for 1 year.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2027-12-10
Completion
2028-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279597 on ClinicalTrials.gov