Locally Advanced Cervical Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Concurrent chemoradiotherapy combined with targeted therapy
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old, female; Karnofsky performance status (KPS) >=70; 2. Cervical squamous cell carcinoma was confirmed by histopathology, FIGO 2018 stage IB3-IVA; 3. No distant metastasis, considered as inoperable by two gynecological oncologists with deputy chief physician or above qualification (loss of opportunity for radical surgery); 4. EGFR was positive in tumor tissue. 5. Expected survival time >=6 months; 6. Normal major organ function (hemoglobin >=90 g/L, neutrophil count >=1.5×10^9/L, platelet count >=100×10^9/L, serum creatinine, ALT/AST <=1.5× upper limit of normal, etc.); 7. All subjects voluntarily participated in this study and signed informed consent
Exclusion criteria
Exclusion criteria: 1. Those whose distant metastasis has been confirmed by imaging or clinical examination; 2. Those whose tumor size cannot be accurately assessed due to anatomical structure reasons; 3. Those who cannot complete necessary examination and evaluation due to medical conditions or patient reasons (for example, unable to undergo pelvic MRI examination); 4. Those who have previously received radiotherapy to the pelvic area, platinum-based chemotherapy, EGFR targeted therapy or other systemic treatment for cervical cancer; 5. Those who have suffered from other malignant tumors within the past 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ); 6. Those who participated in other clinical trials within 4 weeks before enrollment, or are currently participating in other research interventions; 7. Those who have a history of >= grade 3 severe allergic reactions to nimotuzumab or any drug components used in the trial; 8. Those who have concurrent severe chronic diseases that are uncontrollable (such as unstable angina pectoris, congestive heart failure, severe pulmonary insufficiency, active gastrointestinal ulcer bleeding, etc.) and are unable to tolerate the treatment of this study; 9. Those who have active infections (such as active tuberculosis, hepatitis B virus infection, etc.) or other severe infectious diseases; 10. Pregnant or lactating women, or women of childbearing age who are unwilling to take reliable contraceptive measures during the study period; 11. Patients who, in the judgment of the investigator, are not suitable to participate in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;The 2-year progression-free survival (PFS) rate;Complete response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant metastasis-free survival;2-year local control rate;Changes in quality of life;Correlation between baseline EGFR expression level and treatment efficacy;Severity of adverse events;Incidence of adverse events;2-year overall survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactChenying Ma
The First Affiliated Hospital of Soochow University
Outcome results
None listed