A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-… (NCT07279597) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer
45 participantsStarted 2025-12-10
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. Male or female ≥18 years of age;
✓. ECOG Performance Status: 0-1;
✓. Patients must have undergone pathological biopsy and imaging diagnosis, and be judged by the investigator to have muscle-invasive bladder urothelial carcinoma (urothelial carcinoma as the main pathological component \>50%);
✓. Normal function of major organs (within 14 days before enrollment), meeting the following standards:
✓. Hematological criteria must be met (no blood transfusion or granulocyte colony-stimulating factor treatment within 14 days before enrollment):
Exclusion criteria
✕. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy, including during the adjuvant therapy phase;
✕. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components;
✕. Received other anti-tumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of study treatment, or have not recovered from previous toxicity (except for Grade 2 alopecia and Grade 1 neurotoxicity);
What they're measuring
1
Complete Response (CR)
Timeframe: Complete Response (CR) rate at 3 months after radiotherapy completion
✕. Patients with active Hepatitis B or Hepatitis C: HBsAg or HBcAb positive with concurrently positive HBV DNA copy number (quantitative detection limit of 500 IU/ml, or reaching the positive copy number value detected by the research center); HBV DNA must be tested during study screening for these patients; Patients with positive HCV antibody test results can only be enrolled in this study if the PCR test result for HCV RNA is negative.
✕. History of definite active tuberculosis;
✕. Active autoimmune disease requiring systemic treatment in the past 2 years (e.g., using disease-modifying drugs, corticosteroids, or immunosuppressive drugs). Related replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) is allowed;