Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma

Launched by CHUNGUANG YANG (101937) · Feb 9, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with muscle-invasive bladder cancer, specifically looking at the combination of two drugs: Disitamab Vedotin (RC48-ADC) and gemcitabine. The goal is to see how effective and safe this combination is when given before surgery, called radical cystectomy, which involves removing the bladder and surrounding tissues. Researchers hope that this study will provide valuable information about using these drugs together to improve treatment outcomes for patients with this type of cancer.

To participate in this trial, individuals must be between the ages of 18 and 75, have a confirmed diagnosis of urothelial carcinoma, and be scheduled for surgery. They should also have a specific stage of cancer and meet certain health criteria. Participants can expect to receive the study treatment and will be closely monitored throughout the trial. It's essential to know that individuals with certain medical conditions or recent treatments may not be eligible to join. If you or a loved one are considering participation, please discuss it with your healthcare provider to see if it’s a good fit.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects voluntarily joined the study, signed the informed consent form, and were able to follow the study and follow-up procedures
• • 2. Age 18-75
• • 3. Suitable and planned for radical cystectomy (including lymph node dissection)
• • 4. Clinical stage T2-T4aN0M0 (CT/MR/PET-CT evaluation)
• • 5. Pathologically, it is urothelial carcinoma, and the patient has HER2 expression and refuses neoadjuvant chemotherapy or physical condition/renal function \[glomerular filtration rate (GFR) 30-60mL/min\], which is not suitable for neoadjuvant chemotherapy (pathology allows urothelial carcinoma to merge with other variant subtypes, with urothelial carcinoma as the main type)
• • 6. ECOG score 0 or 1
• • 7. There is residual tumor after TURBT (cystoscopy or imaging evidence)
• • 8. The blood test of subjects should meet the following requirements
• Exclusion Criteria:
• • 1. Receive live attenuated vaccine within 4 weeks before enrollment or during the study period.
• • 2. Have received systemic chemotherapy and targeted therapy of anti-PD-1, PD-L1 and HER2 in the past 6 months
• • 3. Known allergy to gemcitabine/RC48 and its components
• • 4. Active, known or suspected autoimmune diseases.
• • 5. A history of primary immunodeficiency is known.