Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cervical Cancer
- Cervical Neoplasms
- Cervix Cancer
- Uterine Cervical Neoplasms
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 re...
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).
Tracking Information
- NCT #
- NCT04096911
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Investigators
- Study Chair: Buhai Wang People's hospital of northern jiangsu Study Director: Yuechao Wu People's hospital of northern jiangsu
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