NCT05723991

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2022

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2025

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 1, 2023

Last Update Submit

February 9, 2023

Conditions

Radical CystectomyUrothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    three years

Study Arms (1)

Vidiximab and Gemcitabine Neoadjuvant therapy

EXPERIMENTAL

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

Drug: Disitamab Vedotin and Gemcitabine

Interventions

Disitamab Vedotin and GemcitabineDRUG

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)

Vidiximab and Gemcitabine Neoadjuvant therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Wuhan, Hubei, 430000, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

disitamab vedotinGemcitabine

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Zhiquan hu, doctor

    Tongji Hospital

    STUDY DIRECTOR

Central Study Contacts

Zhiquan hu, doctor

CONTACT

13971656164huzhiquan2000@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 13, 2023

Study Start

September 28, 2022

Primary Completion

September 28, 2024

Study Completion

September 28, 2025

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)