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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Lei Li | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Lei Li |
China,
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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