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Trial Title:
Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma
NCT ID:
NCT05723991
Condition:
Radical Cystectomy
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Gemcitabine
Disitamab vedotin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin and Gemcitabine
Description:
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)
Arm group label:
Vidiximab and Gemcitabine Neoadjuvant therapy
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiquan hu
Facility:
Name:
Tongji Hospital
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiquan hu
Start date:
September 28, 2022
Completion date:
September 28, 2025
Lead sponsor:
Agency:
Chunguang yang (101937)
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05723991
