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Clinical Trials/NCT05310305
NCT05310305
Unknown
Not Applicable

Combination of Immune Checkpoint Inhibitors PD-1 Monoclonal Antibody and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Retrospective Cohort Study

Lei Li1 site in 1 country20 target enrollmentMarch 26, 2022
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ConditionsImmune Checkpoint InhibitorsAnti-programmed Death-1 AntibodyRadiotherapyRecurrent Cervical CarcinomaMetastatic Cervical CarcinomaPersistent Advanced Cervical CarcinomaObjective Remission RateProgression-free SurvivalOverall SurvivalSevere Adverse Events

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immune Checkpoint Inhibitors
Sponsor
Lei Li
Enrollment
20
Locations
1
Primary Endpoint
Objective remission rate
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study is to investigate retrospectively the effects of combination of immune checkpoint inhibitors anti-programmed death-1 antibody (PD-1 antibody) and radiotherapy for recurrent, metastatic and persistent advanced cervical carcinomas. Patients may or may not accept PD-1 antibody as maintenance therapy. Patients are followed up and the survival outcomes are evaluated. The primary endpoint are objective remission rate. The secondary endpoints are progression-free survival, overall survival and severe adverse events.

Registry
clinicaltrials.gov
Start Date
March 26, 2022
End Date
March 26, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Lei Li
Responsible Party
Sponsor Investigator
Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • •Aged 18 years or older
  • •Confirmed of recurrent, metastatic, and persistent advanced cervical cancer
  • •Confirmed of subtypes of cervical squamous carcinoma, adenocarcinoma and adenosquamous carcinoma
  • •Accepting radiotherapy with concurrent anti PD-1 therapy
  • •With detailed follow-up outcomes

Exclusion Criteria

  • •Not meeting all of the inclusion criteria

Outcomes

Primary Outcomes

Objective remission rate

Time Frame: One year

Objective remission rate in one month after the end of radiotherapy

Secondary Outcomes

  • Progression-free survival(One year)
  • Overall survival(One year)
  • Severe adverse events(Two years)

Study Sites (1)

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