PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer | NCT05310305

Studies
PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

NCT05310305

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Apr 11, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

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

Interventions

Radiotherapy for targeted lesions and PD-1 antibody

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2022Actual

Primary Completion Date

Sep 26, 2022Estimated

Completion Date

Mar 26, 2023Estimated

First Submitted Date

Mar 26, 2022

First Submission Date that Met QC Criteria

Mar 26, 2022

First Posted Date

Apr 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2022

Last Update Posted Date

Apr 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy for targeted lesions and PD-1 antibody	Combination Product	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective remission rate	Objective remission rate in one month after the end of radiotherapy	One year

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival	Progression-free survival after the end of radiotherapy	One year
Overall survival	Overall survival after the end of radiotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with recurrent, metastatic and persistent advanced cervical carcinomas

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Li, M.D.	Contact	86-139-1198-8831		lileigh@163.com

Overall Officials

Name	Affiliation	Role
Lei Li, M.D.	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	Beijing Municipality	100730	China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases