Combination treatment of Disitamab Vedotin and Gemcitabine for bladder cancer

Evaluation of an Open, Single Arm, Multicenter Phase II Clinical Study on the Neoadjuvant Treatment of HER2 Expressing Myometrial Invasive Bladder Cancer With Disitamab Vedotin for Injection and Gemcitabine

This study tests if a new combination of two drugs, Disitamab Vedotin and Gemcitabine, can help people with a specific type of bladder cancer who can't take cisplatin chemotherapy.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: chemotherapy, vedixizumab
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT05723991 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Disitamab Vedotin combined with Gemcitabine as a neoadjuvant treatment for patients with myometrial invasive bladder cancer that expresses HER2 and are not suitable for cisplatin chemotherapy. Participants will receive the treatment intravenously every two weeks for three cycles, followed by imaging evaluations to determine the need for radical cystectomy. The study aims to provide high-level clinical evidence for this combination therapy in treating muscle-invasive bladder cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with HER2-expressing urothelial carcinoma, suitable for radical cystectomy, and not eligible for cisplatin chemotherapy.

Not a fit: Patients who have received systemic chemotherapy or have severe renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with muscle-invasive bladder cancer who cannot receive standard chemotherapy.

How similar studies have performed: While this approach is novel in combining Disitamab Vedotin with Gemcitabine for this specific patient population, similar studies have shown promise in using targeted therapies for bladder cancer.

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.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Tongji Hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Zhiquan hu, doctor

Conditions: Radical Cystectomy, Urothelial Carcinoma