cervical cancer
Conditions
Interventions
Interventions group:Adebrelimab combined with Paclitaxel Liposome and Cisplatin
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign an informed consent form (ICF). 2. Age >=18 years and <=75 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Patients with histologically or cytologically confirmed (AJCC TNM 9th edition) T1b3/T2a2/T2bNxM0 stage cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 5. No prior systemic or local anti-tumor treatment for cervical cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, small molecule targeted therapy, etc. 6. Agree to undergo radical hysterectomy and are judged by the investigator to have no contraindications to surgery. 7. According to RECIST v1.1, at least one untreated measurable lesion. 8. The subject agrees to provide tumor tissue and peripheral blood samples required during the screening period and the study for related research. 9. Have good organ function. 10. Female subjects of childbearing potential must undergo urine or serum pregnancy testing within 3 days before the first dose of medication, and the result must be negative. Female subjects of childbearing potential must use acceptable contraceptive methods. 11. The subject is willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with rare pathological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc. 2. Subjects with other malignancies, excluding cervical cancer, within 3 years prior to enrollment. Subjects with other malignancies that have been cured with local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, ductal carcinoma in situ of the breast, etc. 3. Participation in another clinical study concurrently, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study. 4. Patients who request to preserve fertility. 5. Received non-specific immunomodulatory treatment (such as interleukins, interferons, thymic peptides, tumor necrosis factor, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks before the first dose; received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first dose. 6. History of active autoimmune diseases requiring systemic treatment within the past two years. 7. History or current presence of non-infectious pneumonia requiring systemic corticosteroid treatment, or history of interstitial lung disease. 8. History of severe bleeding tendency or coagulopathy. 9. Current uncontrolled comorbidities or psychiatric/social conditions that would limit the subject's ability to comply with study requirements or affect the subject's ability to provide written informed consent. 10. History of myocarditis, cardiomyopathy, or malignant arrhythmias. 11. History of active or past definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea). 12. Serious infection within 4 weeks before the first dose; active infection treated with systemic anti-infective therapy within 10 days before the first dose (excluding antiviral treatment for hepatitis B or C). 13. Major surgical procedure or severe trauma within 30 days before the first dose; minor local surgery within 3 days before the first dose (excluding peripherally inserted central catheterization). 14. History of immunodeficiency; HIV antibody test positive; current long-term use of systemic corticosteroids or other immunosuppressants. 15. Known active tuberculosis (TB), subjects suspected of having active TB must be clinically examined to exclude; known active syphilis infection; untreated active hepatitis B subjects, for subjects with hepatitis B, antiviral treatment for hepatitis B is required during study treatment; active hepatitis C subjects. 16. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 17. Received live vaccines within 30 days before the first dose, or plan to receive live vaccines during the study period. 18. Known allergy to any component of any study medication; known history of severe hypersensitivity reactions to other monoclonal antibodies. 19. Known history of mental illness, drug abuse, alcoholism, or drug addiction. 20. Women who are pregnant or breastfeeding. 21. Past or current existence of any disease, treatment, or laboratory test abnormalities that may confound study results, affect the subject's ability to participate fully in the study, or participation in the study may not be in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progress free survival;Overall Survival;2-year Disease-Free Survival (DFS) rate; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center
Outcome results
None listed