PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

NCT ID: NCT05310305

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-26

Study Completion Date

2023-03-26

Brief Summary

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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.

Detailed Description

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Conditions

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Immune Checkpoint Inhibitors Anti-programmed Death-1 Antibody Radiotherapy Recurrent Cervical Carcinoma Metastatic Cervical Carcinoma Persistent Advanced Cervical Carcinoma Objective Remission Rate Progression-free Survival Overall Survival Severe Adverse Events

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

86-139-1198-8831

Facility Contacts

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Lei Li, MD

Role: primary

008613911988831

Other Identifiers

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IMURADIO1

Identifier Type: -

Identifier Source: org_study_id

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