cancer of cervix
Conditions
Interventions
Treatment group:Eparolitoratoratorimab in combination with TP (cisplatin paclitaxel)
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
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>=100 g/L, WBC>=3.5×10^9 /L, no history of blood transfusion and no bleeding tendency within 7 days; 12. Liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and serum bilirubin are all 60ml/min; 14. Subject is willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and other requirements of 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 malignancies within 3 years prior to enrollment except cervical cancer. Subjects with other malignancies that have been cured by local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, breast in situ, etc.; 3. Enrollment in another clinical study at the same time, unless it is an observational, non-interventional clinical study or follow-up period of an interventional study; 4. Patients who require reproductive function preservation; 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 concomitant serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; 6. Current uncontrolled comorbid disease or mental illness/social situation that would limit the subject's compliance with the study requirements or affect the subject's ability to provide written informed consent; 7. Patients with peripheral neuropathy of grade >=2 according to CTCAE V5.0; 8. Patients with hearing impairment of grade >=2 according to CTCAE V5.0; 9. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia; 10. Known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 11. Major surgical procedures or severe trauma within 30 days before the first dose; Minor local surgery (excluding transperipheral venipuncture central venous catheterization) within 3 days prior to the first dose; 12. Received any other investigational drug treatment or participated in other interventional clinical studies within 30 days before screening; 13. 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 steroid hormones and adrenal hormone replacement therapy at > 10 mg prednisone equivalent per day are allowed in the absence of active autoimmune disease; 14. Subjects with known active tuberculosis (TB) and suspected active TB need to be excluded by clinical examination; Known active syphilis infection; Subjects with untreated active hepatitis B, for subjects with hepatitis B, require anti-hepatitis B virus therapy during the study treatment period; Active hepatitis C subjects; 15. Active infection requiring treatment or use of systemic anti-infective drugs within 1 week before the first dose; 16. Use of live vaccines within 30 days before the first dose and during the trial; 17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 18. Any previous or current disease, treatment, laboratory abnormality that may confound the results of the study, affect the subject's participation in the study throughout the study, or may not be in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival;Disease Free Survival;Pathological Complete Response rate; | — |
Countries
China
Contacts
Public ContactJianhua Yang; Benxing Gu
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed