Evaluate Efficacy and Safety of Serplulimab（HLX10）in Patients With Advanced, Recurrent and Metastatic Cervical Cancer：A Prospective, Multicenter, Non-interventive Real-world Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Beihua Kong, MD.PhD.
kongbeihua@sdu.edu.cn
+8618560081888
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 118
Treatments
Cohort 1
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.
Related Therapeutic Areas
Sponsors
Leads: Shandong University