To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.
This study adopts a multi-center, randomized controlled, open-label clinical trial design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.
Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.
Peking University 3rd Hospital
Beijing, Beijng, China
3-year progression-free survival (PFS)
The rate of patient without progress disease in 3 years after treatment
Time frame: up to 3 years
3-year overall survival (OS)
The rate of patient alive in 3 years after treatment
Time frame: up to 3 years
Complete response rate (CRR)
Percentage of subjects in this group who achieve complete response by imaging assessment from the end of treatment to disease progression.
Time frame: 3 months later after treatment
Objective response rate (ORR)
The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.
Time frame: 3 months later after treatment
Incidence and severity of acute adverse events
Number and grade of participants with adverse events
Time frame: up to 3 months complete treatment
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Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 \~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.