Cervical Cancer
Conditions
Brief summary
This study is a Prospective, Multicenter, non-interventive Real-world Study to evaluate the efficacy and safety of the treatment of Serplulimab in patients with Advanced,Recurrent and Metastatic Cervical Cancer. Approximately 118 eligible subjects are planned to be enrolled across all sites.
Interventions
DRUGSerplulimab
Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Sponsors
Shandong University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years at time of study entry. * Histologically or cytologically confirmed advanced, recurrent or metastatic cervical cancer. * Received at least 1 prior systemic therapies in the recurrent or metastatic setting. Tumor progression or recurrence after treatment with therapy. * ECOG performance status of 0 or 1. * Patient must have at least one measurable disease as defined by RECIST 1.1. * Ability to provide written and signed informed consent.
Exclusion criteria
* Pregnant or lactating women. * Life expectancy \< 3 months * Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 14 days from the end of treatment in the previous clinical study. * Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody. * The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 24 months | Objective Response Rate is defined as the percentage of patients with Complete Response or Partial Response, as assessed by Response Evaluation Criteria in Solid Tumors v.1.1 criteria or immune Response Evaluation Criteria in Solid Tumors v.1.1 criteria by investigators. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Baseline up to approximately 36 months | OS, defined as the time from initiation of study treatment to death from any cause. To assess clinical effectiveness of any serplulimab single used or combined therapy involved in this study by assessment of overall survival (OS) in patients with cervical Cancer. Time intervals for tumor assessment is every 6 or 12 week . |
| Duration of response (DOR) | Up to approximately 24 months | Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. |
| Time to the first disease progression | Up to approximately 24 months | Ddefined as the interval between the date of the initial medication and the time of imaging progression. |
| Progression free survival (PFS) | Up to approximately 24 months | Progression free survival is defined as the time from the first day of serplulimab administration to progression disease or death，whichever occurs first, by the investigator according to Response Evaluation Criteria in Solid Tumors v.1.1 criteria or immune Response Evaluation Criteria in Solid Tumors v.1.1 criteria. |
| 1-year and 2-year Overall Survival Rate | Baseline up to approximately 24 months | OS, defined as the time from initiation of study treatment to death from any cause. OS Rate was defined as the percentage of participants that are OS event-free over 1-year and 2-year. |
| 1-year and 2-year Disease Control Rate | Baseline up to approximately 24 months | Percentage of all evaluable Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD) from first administration to 1-year and 2-year. |
| 1-year and 2-year Progression free survival Rate | Baseline up to approximately 24 months | PFS is defined as the time from first administration to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS Rate was defined as the percentage of participants that are PFS event-free over 1-year and 2-year. |
Countries
China
Contacts
Primary ContactBeihua Kong, MD.PhD.
Outcome results
None listed