Actively Recruiting
Nimotuzumab Plus Definite Chemoradiotherapy(dCRT) in Elderly Patients With Esophageal Squamous Cell Carcinoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-05-25
95
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma.
CONDITIONS
Official Title
Nimotuzumab Plus Definite Chemoradiotherapy(dCRT) in Elderly Patients With Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteered and signed informed consent with good compliance
- Age 70 years or older, any gender
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed esophageal squamous cell carcinoma
- At least one measurable lesion as per RECIST 1.1 criteria, untreated by local therapy except prior radiotherapy with confirmed progression
- Stage II to IVB disease (IVB limited to supraclavicular or abdominal lymph node metastasis without other distant metastases)
- Able to tolerate concurrent radiotherapy, chemotherapy, and targeted therapy
- Expected survival of at least 6 months
- Adequate organ function including hemoglobin ≥90 g/L, ANC ≥1.5×10⁹/L, platelets ≥80×10⁹/L, albumin ≥30 g/L, ALT and AST ≤2.5 times upper limit of normal, total bilirubin ≤1.5 times upper limit of normal, plasma creatinine ≤1.5 times upper limit of normal or creatinine clearance ≥60 ml/min
- Left ventricular ejection fraction at or above 50%
- If of childbearing potential, agree to contraception during study and 6 months after; negative pregnancy test and not breastfeeding
You will not qualify if you...
- Received EGFR monoclonal antibody or EGFR tyrosine kinase inhibitors within 6 months
- Participation in other interventional clinical trials within 30 days prior to screening
- Serious concurrent illnesses such as heart failure, uncontrolled arrhythmia, severe myocardial infarction, intractable hypertension, advanced kidney failure (CKD-4 or higher), thyroid insufficiency, mental illness, diabetes, severe chronic diarrhea, or deemed unsuitable by investigators
- Symptomatic brain metastases or brain metastases with symptom control less than 3 months
- History of other malignant tumors except cured cervical carcinoma in situ or basal cell carcinoma of the skin or other cancers cured over 5 years ago
- Active infections or infectious diseases
- Multilevel esophageal malignancy or signs of esophageal fistula or perforation
- Tumor invasion or high risk of invasion to important blood vessels
- Allergy to study drugs or their components
- Grade 2 or higher peripheral neuropathy or hearing loss
- Pregnant or breastfeeding women
- History of substance abuse or uncontrolled mental disorders
- Investigator deems participant unfit or unwilling or unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
X
Xiaolin MM GE, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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