Spots Global Cancer Trial Database for Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer

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Trial Identification

Brief Title: Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer

Official Title: A Single-arm, Single-center, Phase II Clinical Study Evaluating Efficacy of PD-1 Monoclonal Antibody Combined With HPV Vaccine in the Patients With Cervical Cancer（CC）Who Fails in or Can Not Endure the Standard Treatment

Study ID: NCT04096911

Conditions

Uterine Cervical Neoplasms

Cervical Cancer

Cervical Neoplasms

Cervix Cancer

Interventions

Sintilimab

quadrivalent HPV vaccine

Study Description

Brief Summary: The investigators propose to evaluate the efficacy of the combination of Pd-1 Monoclonal Antibody and HPV Vaccine in the patients with cervical cancer who fails in or can not endure the standard treatment

Detailed Description: The phase II study is a research which treat cervical carcinoma patients who recurred after at least one prior chemotherapy regimen with Sintilimab and HPV Vaccine. The primary endpoint is objective response rate; secondary endpoints are Progression-Free Survival, Overall Survival and duration of response. Efficacy will be assessed according to RECIST 1.1; progression-free survival is the time from study entry to time of progression or death, whichever occurs first; overall survival is the time from study entry to time of death or the date of last contact,. Furthermore, exploratory studies will be performed on archival tumor material (PD-L1 expression, next-generation sequencing).