Cervical cancer
Conditions
Interventions
Experimental group:Paclitaxel 150mg/m^2 + Cisplatin 70mg/m^2, intravenous drip, administered on the first day
Epaloprolitovirilimab (50mg/2mL), dose 5mg/kg, draw the required volume of the drug and slowly inject it into the 0.9% sodium chloride intravenous infusion bag, prepare a diluted solution with a final
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 65 years old with primary cervical cancer. 2. Clinically diagnosed with stage IB3 or IIA2 cervical cancer (FIGO staging, 2018). 3. No distant organ metastasis, and the short diameter of retroperitoneal lymph nodes is less than 1 cm; According to RECIST version 1.1 criteria, the diameter of the measurable cervical lesion assessed by imaging was greater than 4 cm. 4. Histological type includes cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma; No previous radiotherapy, chemotherapy, or targeted therapy; 5. The expected survival time is more than 3 months; 6. Eastern Cooperative Oncology Group (ECOG) score 0-1; 7. Vital organ function meets the requirements of surgery, chemotherapy and radiotherapy.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors; 2. Pregnant or postpartum patients; 3. Patients with myocardial infarction or stroke, or unstable angina pectoris, decompensated heart failure, or deep vein thrombosis; 4. According to the NCI-CTCAE 5.0 standard, patients with >=2 grade arrhythmia, any grade atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia that requires treatment or intervention; 5. Patients with active pneumonia or hepatitis who present with progressive loss of appetite, general weakness, nausea, acid reflux, belching, anorexia, abdominal distension, and clinical manifestations such as abnormal liver function and jaundice, such as yellow eyes, urine, etc.; 6. Patients with abnormal liver function (aspartate/alanine aminotransferase > 2.5 times the upper limit of the standard); 7. Patients with renal insufficiency (serum creatinine > 2 times the upper limit of the standard); 8. Patients with a history of restrictive respiratory dysfunction from chronic lung diseases; 9. Patients with a history of important organ transplantation or immune disease; 10. Patients with a history of severe mental illness or brain dysfunction; 11. History of drug abuse or drug use; 12. Using immunosuppressants, or systemic hormone therapy to achieve immunosuppression (dose > 10 mg prednisone or other effective hormones), and continuing to use within 2 weeks before enrollment; 13. Coagulation abnormalities (INR > 2.0, PT > 16 seconds), bleeding tendency or undergoing thrombolysis or anticoagulation treatment, allowing for prophylactic use of low-dose aspirin, low-molecular-weight heparin; 14. Congenital or acquired immunodeficiency (such as HIV infection); 15. Received live vaccines within 30 days before the first dose; 16. Unable or unwilling to sign the informed consent form or comply with the study requirements; 17. Having a history, disease or laboratory abnormality that may interfere with test results or prevent the subject from participating in the study, or the investigator believes that participating in the study is not in the best interests of the subject; 18. Patients with stage IV disease who have metastases in solid organs (such as liver, bone, lung, brain, adrenal gland, etc.) at the time of initial diagnosis and cannot undergo surgical treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival period;2-year progression-free survival rate;Safety; | — |
Countries
China
Contacts
Public ContactWei Sheng
Shandong Provincial Hospital
Outcome results
None listed