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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723991
• Other study ID #: [222] LSZ (S137) No
• Status: Recruiting
• Phase: Phase 4
• Start date: September 28, 2022
• Est. completion date: September 28, 2025

Study information

• Verified date: February 2023
• Source: Tongji Hospital
• Contact: Zhiquan hu, doctor
• Phone: 13971656164
• Email: huzhiquan2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients with myometrial invasive bladder cancer expressing HER2 and not suitable for cisplatin chemotherapy were treated with vedixizumab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90min); Gemcitabine is 1000mg/m2, once every two weeks. After completing 3 cycles of neoadjuvant combined therapy, imaging evaluation was performed. If the tumor is T0, radical surgery for bladder cancer was performed; Otherwise, perform radical surgery for bladder cancer (total cystectomy+standard/extended lymph node dissection) after completing 1-3 cycles of treatment.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Radical Cystectomy
• Urothelial Carcinoma

Intervention

Drug:
• Disitamab Vedotin and Gemcitabine
Disitamab Vedotin (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Gemcitabine is 1000mg/m2, once every two weeks. After completing 3 cycles of neoadjuvant combined therapy, imaging evaluation was performed. If the tumor is T0, radical surgery for bladder cancer was performed; Otherwise, perform radical surgery for bladder cancer after completing 1-3 cycles of treatment (total cystectomy+standard/extended lymph node dissection)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chunguang yang (101937)

Country where clinical trial is conducted

China, 

Outcome

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