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NCT05310305 Clinical Trial

PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

Radiotherapy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05310305
Other study ID # IMURADIO1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 26, 2022
Est. completion date March 26, 2023

Study information
Verified date April 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 26, 2023
Est. primary completion date September 26, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Radiotherapy for targeted lesions and PD-1 antibody
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.

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective remission rate Objective remission rate in one month after the end of radiotherapy One year
Secondary Progression-free survival Progression-free survival after the end of radiotherapy One year
Secondary Overall survival Overall survival after the end of radiotherapy One year
Secondary Severe adverse events Severe adverse events during the radiotherapy and the follow-up stage Two years
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