An Exploratory Clinical Study of Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.
• Voluntary participation in clinical research.
• Age ≥18 years old, female.
• Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology.
• Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) .
• At least one measurable lesion was suitable for target lesion according to RECIST v1.1 .
• Within 14 days before the first treatment, the major organ functions were basically normal.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
• Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection;
• If hepatitis B surface antigen (HBsAg) is positive and/or hepatitis B core antibody (HBcAb) is positive, hepatitis B virus DNA (HBV DNA) is detected, HBV DNA \< 104 copies /ml or \< 2000IU/mL can be enrolled. Or those who had received antiviral therapy for at least 4 weeks before the first dose of study drug and were willing to continue antiviral therapy during the study were eligible for enrollment. Those with HCV antibody positive should be excluded.
⁃ Subjects of childbearing age and their sexual partners agreed to consent to contraceptive use after signing an informed consent form, during treatment and for at least 6 months after the last dose of the study intervention.