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

NCT05723991 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-02-13

No results posted yet for this study

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

Conditions

Interventions

DRUG

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)

Sponsors & Collaborators

  • Chunguang yang (101937)

    lead OTHER

Principal Investigators

  • Zhiquan hu, doctor · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2024-09-28
Completion
2025-09-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05723991 on ClinicalTrials.gov