Urothelial Carcinoma Clinical Trial
Official title:
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
A multicenter, open, single arm, phase II clinical trial was designed for myometrial invasive bladder cancer to evaluate the efficacy and safety of RC48-ADC combined with gemcitabine in preoperative neoadjuvant treatment of MIBC, and provide high-level clinical evidence for gemcitabine combined with ADC in the treatment of MIBC
Status | Recruiting |
Enrollment | 36 |
Est. completion date | September 28, 2025 |
Est. primary completion date | September 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital | Wuhan | Hubei |
China | Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Chunguang yang (101937) |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic Complete Response | Neoadjuvant therapy and postoperative pathology confirmed that the primary tumor was in complete remission (stage ypT0) and had no residual tumor cells, regardless of whether the regional lymph nodes were involved or not. | three years |
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