PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

• Sponsor: Lei Li (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05310305
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Combination Product: Radiotherapy for targeted lesions and PD-1 antibody

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Mar 26, 2022
• Anticipated Primary Completion Date: Sep 26, 2022
• Anticipated Study Completion Date: Mar 26, 2023

Outcome Measures

Primary Outcome Measures

1. Objective remission rate [One year]

   Objective remission rate in one month after the end of radiotherapy

Secondary Outcome Measures

1. Progression-free survival [One year]

   Progression-free survival after the end of radiotherapy

2. Overall survival [One year]

   Overall survival after the end of radiotherapy

3. Severe adverse events [Two years]

   Severe adverse events during the radiotherapy and the follow-up stage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Lei Li

Investigators

• Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT05310305
• Other Study ID Numbers: IMURADIO1
• First Posted: Apr 4, 2022
• Last Update Posted: Apr 11, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Uterine Cervical Neoplasms; Recurrence; Antibodies

Study Results

No Results Posted as of Apr 11, 2022