cervical cancer
Conditions
Interventions
Experimental group:Epalolitovarelimab in combination with TP (cisplatin paclitaxel)
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old=1.5×10^9/L, platelet count>=100×10^9/L, Hb>=100g/L, WBC>=3.5×10^9/L, no history of blood transfusion and no bleeding tendency within 7 days; 8. Liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and serum bilirubin are all 60mL/min; 10. Volunteer to participate in this study, sign the informed consent form, and be able to comply with the visits, examinations, and treatment plans stipulated by the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with rare histopathological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc.; 2. Subjects have other malignant tumors within 5 years prior to enrollment except cervical cancer; 3. Enrolled in another clinical study at the same time; 4. Requiring reproductive function to be preserved; 5. In the opinion of the investigator, there are uncontrolled serious medical diseases that will affect the subject to receive treatment under the study protocol, such as complicated serious medical diseases, including: severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; 6. Patients with peripheral neuropathy of grade >=2 according to CTCAE V5.0; 7. Patients with hearing impairment of grade >=2 according to CTCAE V5.0; 8. Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS); 9. Major surgical procedures or severe trauma within 30 days before the first dose; 10. Patients who require systemic treatment with glucocorticoids (> 10mg of prednisone equivalent dose per day) or other immunosuppressive drugs within 14 days prior to randomization. Inhaled or topical steroids and adrenal hormone replacement therapy > 10mg prednisone equivalent per day are allowed in the absence of active autoimmune disease; 11. Use of live vaccines within 30 days prior to the first dose and during the trial; 12. Received systemic or local anti-tumor therapy for cervical cancer before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR rate, safety of neoadjuvant regimens;Event Free Survival, EFS;Disease Free Survival, DFS;Overall Survival, OS;Incidence of grade III/IV adverse reactions;Quality of life score; | — |
Countries
China
Contacts
Public ContactGu Benxing
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed