Clinical trial NCT05883670: Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer
Official title: Evaluate Efficacy and Safety of Serplulimab（HLX10）in Patients With Advanced, Recurrent and Metastatic Cervical Cancer：A Prospective, Multicenter, Non-interventive Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to approximately 24 months
measure: Overall Survival (OS)
timeFrame: Baseline up to approximately 36 months
measure: Duration of response (DOR)
timeFrame: Up to approximately 24 months
measure: Time to the first disease progression
timeFrame: Up to approximately 24 months
measure: 1-year and 2-year Progression free survival Rate
timeFrame: Baseline up to approximately 24 months
measure: 1-year and 2-year Overall Survival Rate
timeFrame: Baseline up to approximately 24 months
measure: 1-year and 2-year Disease Control Rate
timeFrame: Baseline up to approximately 24 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Beihua Kong, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References: