cervical cancer
Conditions
Interventions
Experimental Group:AK104 combined with neoadjuvant chemotherapy plus radiotherapy and sequential AK104 in the treatment of advanced cervical cancer
Control Group:Neoadjuvant chemotherapy plus radiotherapy for advanced cervical cancer
Sponsors
Nantong Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old; 2. Advanced and recurrent cervical cancer patients with clear pathological diagnosis; 3.2018 FIGO Staging: III-IVA; 4. The United States Eastern Oncology Consortium (ECOG) physical status score was 0 to 1; 5. The expected survival period is not less than 6 months; 6. The investigator is suitable for concurrent chemoradiotherapy; 7. Total white blood cells greater than 4×109/L; 8. Total platelet count is greater than 100×109/L; 9. No history of other malignant tumors; 10. Female subjects of childbearing age have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures during the clinical trial; 11. Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. History of other malignant tumors; 2. Patients with distant metastasis; 3. Patients who received tumor treatment before or during the study;4. Severe nonoperative disease or acute infection; 5. Peripheral polyneuropathy >NCI Grad I; 6. Impaired blood system, liver and kidney function. The evaluation criteria were as follows: blood routine: white blood cells (WBC) 1.5 times the upper limit of normal value; Urea nitrogen (BUN) > 1.5 times the upper limit of normal value; Creatinine (Cr) > 1.5 times the upper limit of normal; Alanine aminotransferase and aspartate aminotransferase (ALT and AST) were 2.5 times higher than the upper limit of normal values. 8. Subjects with obvious clinical manifestations of arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular heart disease; 9. Subjects with severe bone marrow failure; 10. Uncontrollable mental subjects; 11. Pregnant or lactating subjects; 12. Subjects that the researcher considers unfit to participate in this experiment; 13. Is participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;Overall survival at 2 years;DMFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS; | — |
Countries
China
Contacts
Public ContactHe Aiqin
Nantong Tumor Hospital
Outcome results
None listed