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

NCT07053735 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025-209
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

bladder cancer; TMT; radiation oncology

Outcome Measures

Primary Outcomes (3)

• ORR

  1 year

• PFS

  5 years

• OS

  5 years

Study Arms (1)

Nim

EXPERIMENTAL

Drug: Nimotuzumab and Radiotherapy

Interventions

Nimotuzumab and Radiotherapy DRUG

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

Nim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent. Aged ≥18. Histologically confirmed urothelial carcinoma of the bladder, staged T2a-T4a, anyN, M0, or recurrent T1 high - grade tumors (7th - edition AJCC staging).
• Unsuitable or intolerant to cystectomy, or with comorbidities making systemic chemotherapy intolerable, or chemotherapy - averse, or recurrent after prior TURBT and unsuitable for further TURBT or cystectomy.
• ECOG performance status 0-2. No severe hematopoietic or major organ dysfunction, or immunodeficiency. Pre - enrollment lab values: white blood cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L, platelets ≥50×10⁹/L, hemoglobin ≥90 g/L; renal: serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min; hepatic: total bilirubin ≤3.0×ULN, AST/ALT ≤2.0×ULN; coagulation: INR ≤2.0.
• Agreed contraception during the trial for fertile individuals; females of childbearing potential must have a negative pregnancy test within 7 days before initial dosing.
• No prior chemotherapy, targeted, or immunotherapy for cancer.

You may not qualify if:

• Metastatic cancer. Previous pelvic/abdominal radiotherapy. Uncontrolled infection, intractable epilepsy, high intracranial pressure, hypertension, hyperglycemia, angina (Grade 1/symptomatic/≥Grade 2), peripheral neuropathy, or a history of myocardial infarction/heart failure within 6 months, or jaundice due to hepatic insufficiency.
• HIV, active hepatitis B (HBsAg and HBV - DNA positive), or active hepatitis C (HCV - RNA positive).
• Major surgery within 4 weeks before enrollment. Participation in another clinical trial within 4 weeks before enrollment. Other uncontrolled malignancies within the past 5 years (except cervical in - situ carcinoma, squamous cell skin cancer, or localized basal cell carcinoma).
• Any other researcher - identified reason making participation unsuitable.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Neoplasms; Urinary Bladder Neoplasms

Interventions

nimotuzumab; Radiotherapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06