PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer
Combination of Immune Checkpoint Inhibitors PD-1 Monoclonal Antibody and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Retrospective Cohort Study
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2022
CompletedStudy Start
First participant enrolled
March 26, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2023
CompletedApril 11, 2022
April 1, 2022
6 months
March 26, 2022
April 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Objective remission rate
Objective remission rate in one month after the end of radiotherapy
One year
Secondary Outcomes (3)
Progression-free survival
One year
Overall survival
One year
Severe adverse events
Two years
Interventions
Radiotherapy for targeted lesions in all enrolled participants, with concurrent PD-1 antibody. Patients may or may not accept subsequent PD-1 as maintenance therapy.
Eligibility Criteria
Patients with recurrent, metastatic and persistent advanced cervical carcinomas
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lei Lilead
Study Sites (1)
Lei Li
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Li, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 26, 2022
First Posted
April 4, 2022
Study Start
March 26, 2022
Primary Completion
September 26, 2022
Study Completion
March 26, 2023
Last Updated
April 11, 2022
Record last verified: 2022-04