PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

April 1, 2022 updated by: Lei Li

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with recurrent, metastatic and persistent advanced cervical carcinomas

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate
Time Frame: One year
Objective remission rate in one month after the end of radiotherapy
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: One year
Progression-free survival after the end of radiotherapy
One year
Overall survival
Time Frame: One year
Overall survival after the end of radiotherapy
One year
Severe adverse events
Time Frame: Two years
Severe adverse events during the radiotherapy and the follow-up stage
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2022

Primary Completion (Anticipated)

September 26, 2022

Study Completion (Anticipated)

March 26, 2023

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

March 26, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMURADIO1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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