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

NCT ID: NCT05723991

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2025-09-28

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.

Conditions

Radical Cystectomy; Urothelial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vidiximab and Gemcitabine Neoadjuvant therapy

Vidiximab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Gemcitabine is 1000mg/m2, once every 2 weeks

Group Type: EXPERIMENTAL

Disitamab Vedotin and Gemcitabine

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chunguang yang (101937)

OTHER

Sponsor Role: lead

Responsible Party

Chunguang yang (101937)

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhiquan hu, doctor

Role: STUDY_DIRECTOR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiquan hu, doctor

Role: CONTACT

huzhiquan2000@163.com

13971656164

Facility Contacts

Zhiquan hu

Role: primary

Zhiquan hu

Role: primary

Other Identifiers

[222] LSZ (S137) No

Identifier Type: -

Identifier Source: org_study_id