cervical cancer
Conditions
Interventions
Treatment Group:Sipuleucel-T Injection Therapy in Combination with Standard Treatment
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects who meet the following inclusion criteria will be enrolled in this study: 1) Aged 18-65 years; 2) Diagnosed with cervical squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma by pathological histology, and have completed pelvic MRI assessment; 3) FIGO 2018 staging of IB3, IIA2, or T>=4cm IIB; 4) ECOG score of 0-2, capable of tolerating chemotherapy; 5) No prior exposure to immunotherapy for malignant tumors; 6) Able to understand this trial and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria will not be included in this study: 1) Have other uncontrolled malignant tumors; 2) Have had any disease within 14 days prior to randomization that requires systemic treatment with corticosteroids (a daily dose of prednisone or equivalent >10mg) or other immunosuppressive drugs. The use of local replacement corticosteroids (a daily dose of prednisone or equivalent <=10mg) and prescription corticosteroids for short-term (<=7 days) prophylactic use or treatment of non-autoimmune conditions is allowed. Have a history of any active autoimmune disease or autoimmune disease; 3) Have a history of active autoimmune disease or autoimmune disease that is likely to relapse. The inclusion of well-controlled Type 1 diabetes, hypothyroidism treated with only hormone replacement therapy, well-controlled celiac disease, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia), or diseases that are not expected to relapse without external causes is allowed; 4) Have a history of interstitial lung disease, non-infectious pneumonia, or poorly controlled diseases (including pulmonary fibrosis, acute lung disease, etc.). 5) Subjects with active hepatitis B (defined as a positive test result for hepatitis B surface antigen [HBsAg] during the screening period with detectable HBV-DNA levels above the upper limit of normal values in the laboratory of the research center) or hepatitis C (defined as a positive test result for hepatitis C virus surface antibody [HCsAb] during the screening period, with positive HCV-RNA); 6) Known human immunodeficiency virus (HIV) infection (known HIV antibody positivity); 7) Have received live vaccines within 30 days prior to the first dose of medication. This includes, but is not limited to, the following: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, BCG (Bacillus Calmette-Guérin), and typhoid vaccines (inactivated viral vaccines are allowed). 8) Have uncontrolled cardiac clinical symptoms or diseases; 9) Have an allergy to any medication in this protocol; 10) Based on the investigator's judgment, subjects with any history or current evidence of diseases, treatments, or laboratory abnormalities that may confound the trial results, interfere with the subject's participation in the entire trial, or are not in the best interest of the subject's participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Size; | — |
Countries
China
Contacts
Public ContactPeifang Chen
Fujian Medical University Union Hospital
Outcome results
None listed