MedTrace Logo

An Exploratory Clinical Study of Nimotuzumab in Bladder - Sparing Chemoradiotherapy for Muscle - Invasive Bladder Cancer

NCT07053735 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-08

No results posted yet for this study

Summary

The goal of this exploratory study is to evaluate the safety and efficacy of nimotuzumab combined with chemoradiotherapy in bladder - preserving treatment for MIBC patients who are ineligible for or decline radical cystectomy. The main questions it aims to answer are:

Does nimotuzumab combined with radiotherapy reduce adverse events in elderly bladder cancer patients? Does this combination improve objective response rate (ORR), progression - free survival (PFS), overall survival (OS), and bladder preservation rate in these patients? Participants will be MIBC patients treated with nimotuzumab and chemoradiotherapy, with a planned 5 - year follow - up to assess treatment efficacy and safety.

Conditions

  • Bladder (Urothelial, Transitional Cell) Cancer

Interventions

DRUG

Nimotuzumab and Radiotherapy

1. nimotuzumab: 200mg, iv, qw, used for 5 weeks. 2. radiotherapy: radiotherapy is performed according to clinical routine;

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-06-30
Completion
2027-06-30

More Related Trials

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 NCT07053735 on ClinicalTrials.gov