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

Last updated: February 9, 2023
Sponsor: Chunguang yang (101937)
Overall Status: Active - Recruiting

Phase

4

Condition

Carcinoma

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT05723991
[222] LSZ (S137) No
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects voluntarily joined the study, signed the informed consent form, and were ableto 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 andrefuses neoadjuvant chemotherapy or physical condition/renal function [glomerularfiltration rate (GFR) 30-60mL/min], which is not suitable for neoadjuvant chemotherapy (pathology allows urothelial carcinoma to merge with other variant subtypes, withurothelial 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

Exclusion Criteria:

  1. Receive live attenuated vaccine within 4 weeks before enrollment or during the studyperiod.
  2. Have received systemic chemotherapy and targeted therapy of anti-PD-1, PD-L1 and HER2in 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.

Study Design

Total Participants: 36
Study Start date:
September 28, 2022
Estimated Completion Date:
September 28, 2025

Study 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.

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Active - Recruiting

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