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

Recruiting

• Conditions: Cervical Cancer
• Interventions: Drug: Serplulimab

• Registration Number: NCT05883670
• Lead Sponsor: Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-06
• Study Start: 2023-03-09
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01
• Primary Completion: 2024-03-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 118

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Serplulimab	The medication plan is determined by gynecological oncology or oncology physician. Select the treatment plan containing serplulimab (single drug and/or combination), the other anti-tumor treatment schemes without intervention. The recommended dose of serplulimab is 300 mg IV, Day1 of each cycle. Apply the drug on the first day of each cycle until the disease progresses or intolerable toxicity occurs.The combined drugs is decided by the doctor. In this non-interventive study, do not change or interfere with the current medical treatment of the recruited patients.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 .
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.
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 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.
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.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China