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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883670
• Other study ID #: ASTRUM-CC02
• Status: Recruiting
• Start date: March 9, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Shandong University
• Contact: Beihua Kong, MD.PhD.
• Phone: +8618560081888
• Email: kongbeihua[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Serplulimab
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.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 24 months
Secondary	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.	Up to approximately 24 months
Secondary	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 .	Baseline up to approximately 36 months
Secondary	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.	Up to approximately 24 months
Secondary	Time to the first disease progression	Ddefined as the interval between the date of the initial medication and the time of imaging progression.	Up to approximately 24 months
Secondary	1-year and 2-year Progression free survival Rate	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.	Baseline up to approximately 24 months
Secondary	1-year and 2-year Overall Survival Rate	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.	Baseline up to approximately 24 months
Secondary	1-year and 2-year Disease Control Rate	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.	Baseline up to approximately 24 months