NCT05723991

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Chunguang yang (101937) · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Radical Cystectomy
• Urothelial Carcinoma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-09-28
• Primary completion: 2024-09-28
• Completion: 2025-09-28
• First posted: 2023-02-13
• Last updated: 2023-02-13

Locations

2 sites across 1 country: China