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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05883670
Other study ID # ASTRUM-CC02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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