Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer

Shandong University118 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

118

Conditions

Cervical Cancer

Interventions

SerplulimabDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

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.

Time frame: Up to approximately 24 months

Secondary Outcomes

Progression free survival (PFS)

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.

Time frame: Up to approximately 24 months

Overall Survival (OS)

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 .

Time frame: Baseline up to approximately 36 months

Duration of response (DOR)

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 frame: Up to approximately 24 months

Time to the first disease progression

Ddefined as the interval between the date of the initial medication and the time of imaging progression.

Time frame: Up to approximately 24 months

1-year and 2-year Progression free survival Rate

Central Contacts

Beihua Kong, MD.PhD.

CONTACT

+8618560081888 kongbeihua@sdu.edu.cn

Data from ClinicalTrials.gov

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