Overview

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

Status:
Recruiting

Trial end date:
2025-09-28

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chunguang yang (101937)

Treatments:

Gemcitabine

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.