Back to resultsStudy of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma
Primary Purpose
Radical Cystectomy, Urothelial Carcinoma
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Disitamab Vedotin and Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Radical Cystectomy
Eligibility Criteria
Inclusion Criteria: Subjects voluntarily joined the study, signed the informed consent form, and were able to follow the study and follow-up procedures Age 18-75 Suitable and planned for radical cystectomy (including lymph node dissection) Clinical stage T2-T4aN0M0 (CT/MR/PET-CT evaluation) 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) ECOG score 0 or 1 There is residual tumor after TURBT (cystoscopy or imaging evidence) The blood test of subjects should meet the following requirements Exclusion Criteria: Receive live attenuated vaccine within 4 weeks before enrollment or during the study period. Have received systemic chemotherapy and targeted therapy of anti-PD-1, PD-L1 and HER2 in the past 6 months Known allergy to gemcitabine/RC48 and its components Active, known or suspected autoimmune diseases. A history of primary immunodeficiency is known.
Sites / Locations
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vidiximab and Gemcitabine Neoadjuvant therapy
Arm Description
Vidiximab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Gemcitabine is 1000mg/m2, once every 2 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05723991
First Posted
February 1, 2023
Last Updated
February 9, 2023
Sponsor
Chunguang yang (101937)
1. Study Identification
Unique Protocol Identification Number
NCT05723991
Brief Title
Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
September 28, 2024 (Anticipated)
Study Completion Date
September 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chunguang yang (101937)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radical Cystectomy, Urothelial Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vidiximab and Gemcitabine Neoadjuvant therapy
Arm Type
Experimental
Arm Description
Vidiximab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Gemcitabine is 1000mg/m2, once every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Disitamab Vedotin and Gemcitabine
Intervention 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)
Primary Outcome Measure Information:
Title
Pathologic Complete Response
Description
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.
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects voluntarily joined the study, signed the informed consent form, and were able to follow the study and follow-up procedures
Age 18-75
Suitable and planned for radical cystectomy (including lymph node dissection)
Clinical stage T2-T4aN0M0 (CT/MR/PET-CT evaluation)
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)
ECOG score 0 or 1
There is residual tumor after TURBT (cystoscopy or imaging evidence)
The blood test of subjects should meet the following requirements
Exclusion Criteria:
Receive live attenuated vaccine within 4 weeks before enrollment or during the study period.
Have received systemic chemotherapy and targeted therapy of anti-PD-1, PD-L1 and HER2 in the past 6 months
Known allergy to gemcitabine/RC48 and its components
Active, known or suspected autoimmune diseases.
A history of primary immunodeficiency is known.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiquan hu, doctor
Phone
13971656164
Email
huzhiquan2000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiquan hu, doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiquan hu
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiquan hu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma
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