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

Sponsor
Shandong University
Study ID
NCT05883670
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 9, 2023
Status verified
May 2023
Primary completion
Mar 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
118 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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