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Trial Title:
Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer
NCT ID:
NCT05883670
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
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.
Arm group label:
Cohort 1
Other name:
HLX10
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.
Criteria for eligibility:
Study pop:
Patients Histologically or cytologically confirmed advanced, recurrent or metastatic
cervical cancer，who received at least 1 prior systemic therapies in the recurrent or
metastatic setting，tumor progression or recurrence after treatment with therapy.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Beihua Kong, MD. PhD.
Phone:
+8618560081888
Email:
kongbeihua@sdu.edu.cn
Start date:
March 9, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shandong University
Agency class:
Other
Source:
Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05883670
