PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

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

• Registration Number: NCT05310305
• Lead Sponsor: Lei Li

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-26
• Study First Submitted: 2022-03-26
• Study First Submitted QC: 2022-03-26
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-09-26
• Study Completion: 2023-03-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective remission rate	One year	Objective remission rate in one month after the end of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	One year	Progression-free survival after the end of radiotherapy
Overall survival	One year	Overall survival after the end of radiotherapy
Severe adverse events	Two years	Severe adverse events during the radiotherapy and the follow-up stage

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China