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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Immune Checkpoint Inhibitors
• Metastatic Cervical Carcinoma
• Overall Survival
• Persistent Advanced Cervical Carcinoma
• Progression-free Survival
• Radiotherapy
• Recurrent Cervical Carcinoma
• Severe Adverse Events
• Uterine Cervical Neoplasms

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