Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer
NCT ID: NCT05883670
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
118 participants
OBSERVATIONAL
2023-03-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Shandong University
OTHER
Responsible Party
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Beihua Kong
professor
Principal Investigators
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Beihua Kong, MD.PhD.
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ASTRUM-CC02
Identifier Type: -
Identifier Source: org_study_id
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