NCT07053735Not yet recruitingPhase 1
An Exploratory Clinical Study of Nimotuzumab in Bladder - Sparing Chemoradiotherapy for Muscle - Invasive Bladder Cancer
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 27 Jun 2025
- Start date
- Jun 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Peking University First Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07053735
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From Jun 2025 to the primary completion date, Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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).
Other illness
- HIV, active hepatitis B (HBsAg and HBV - DNA positive), or active hepatitis C (HCV - RNA positive).
Other
- Any other researcher - identified reason making participation unsuitable.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.