NCT07053735

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Nimotuzumab and Radiotherapy	1. nimotuzumab: 200mg, iv, qw, used for 5 weeks. 2. radiotherapy: radiotherapy is performed according to clinical routine;

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-07-08
• Last updated: 2025-07-08