cervical cancer
Conditions
Interventions
Experimental group:adebrelimab combined with albumin paclitaxel and cisplatin(Q3W, 3 Cycles)?Radical surgery
Sponsors
Lianyungang First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be eligible for admission to this study, students must meet all of the following inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent; 2. Age 18-75 years old; 3. Histologically or cytologically confirmed cervical squamous cell carcinoma and adenocarcinoma, IB2-IIIC with maximum diameter = 2.0cm of cervical tumor (FIGO 2018); 4. ECOG PS score: 0~1 points; 5. Have not received local or systemic anti-tumor therapy for cervical cancer; 6. Agree to undergo radical hysterectomy, and the investigator judges that there is no contraindication to surgery; 7. At least 1 measurable lesion according to RECIST v1.1; 8. The functional level of organs must meet the following requirements: ANC = 1.5×109/L; PLT = 90×109/L; Hb = 90 g/L; TBIL = 1×ULN; ALT and AST = 1.5×ULN, ALP = 2.5×ULN; BUN and Cr = 1× ULN and creatinine clearance = 50 mL/min (Cockcroft-Gault formula); LVEF = 50%; Fridericia Corrected QT Interval (QTcF) male < 450 ms, female < 470 ms; INR = 1.5 x ULN, ACTT = 1.5 x ULN. 9. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, you need to test HBV-DNA, and HBV-DNA needs to be < 2000 IU/mL (if the research center only has copy/mL detection units, it must be < 104 copy/mL); For subjects with HBV-DNA=2000 IU/mL, antiviral therapy (only nucleoside drugs such as Entecavir, tenofovir fumarate, and tenofovir profofovir fumarate tablets were allowed) for at least 1 week prior to initial treatment, and the number of viral copies decreased by more than 10 times (1 lg) compared to before initial treatment. For those infected with HBV, antiviral therapy is required throughout the study period. Hepatitis C virus (HCV) -RNA positive subjects must receive antiviral therapy according to treatment guidelines; 10. Women of childbearing age must have a negative (ßHCG) pregnancy test within 3 days before the first medication. Women and men of childbearing age (who have sex with women of childbearing age) must consent to contraception during treatment and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients with other histopathological types except cervical squamous cell and adenocarcinoma; 2. Have a history of aggressive malignant tumors in the 5 years prior to signing the informed consent, except for fully treated basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, and carcinoma in situ of the breast; 3. Previous recipients of allogeneic stem cells or solid organ transplants; 4. A history of idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening; 5. Active tuberculosis; 6. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-lecithin antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis; 7. Severe infection within 4 weeks prior to initiation of neoadjuvant therapy, including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia; 8. Oral or intravenous antibiotic therapy within 2 weeks before the start of neoadjuvant therapy; 9. Use non-steroidal anti-inflammatory drugs (NSAID) for daily chronic disease treatment; 10. Bleeding diathesis or evidence of significant coagulation dysfunction (without anticoagulation therapy); 11. Current or recent use of aspirin or full dose oral or intravenous anticoagulants; 12. Major vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occurs within 6 months prior to initiation of neoadjuvant therapy; 13. Severe cardiovascular disease (such as New York Heart Association Class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months prior to initiation of neoadjuvant therapy; 14. Severe, non-healing or open wounds, active ulcers or untreated fractures; 15. Major surgery was performed within 4 weeks before neoadjuvant therapy began, or major surgery is expected to be required during the study period; 16. Patients receiving systemic immunosuppressive drugs (including, but not limited to, glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-a (TNF-a) within 2 weeks prior to initiation of neoadjuvant therapy, or who are expected to require systemic immunosuppressive drugs during the study therapy; 17. Subjects who have received or will receive a live vaccine within 30 days prior to initiation of neoadjuvant therapy, or who are expected to require the vaccine during treatment or within 5 months after the last dose; 18. Known allergy to any investigational drug or excipient; 19. Contraindicated use of investigational drugs, any other diseases, metabolic disorders, physical findings or clinical laboratory findings of women who are pregnant, breastfeeding, have given birth but refuse to use contraceptives; 20. Other factors deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Event-free survival;security; | — |
Countries
China
Contacts
Public ContactYang Zhang
Lianyungang First People's Hospital
Outcome results
None listed