Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis

July 11, 2025 updated by: Jianguo Sun, Xinqiao Hospital of Chongqing

Single-cell Sequencing of Bronchoalveolar Lavage Fluid to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis

A multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • Recruiting
        • Xinqiao Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol and sign the written informed consent;
  2. NSCLC patients who have been clinically diagnosed with RP or CIP after histopathologically confirmed radiotherapy or immunocheckpoint inhibitor treatment and have not received glucocorticoid or other drugs.
  3. ≥18 years old, less than 75 years old;
  4. ECOG PS score 0-3 in the Eastern Tumor Collaboration group;
  5. Patients without contraindications to alveolar lavage;

Exclusion Criteria:

  1. Poor patient compliance and violation of test regulations;
  2. Liver and kidney dysfunction, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
  3. Had any medical condition requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment;
  4. Severe infection occurred within 4 weeks prior to enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
  5. Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment;
  6. Untreated patients with chronic hepatitis B, HBV carriers with HBV DNA≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Non-active hepatitis B, surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA & LT; 500 IU/mL), patients with cured hepatitis C could be enrolled;
  7. Known history of HIV infection;
  8. Received any other investigational drug or participated in any other clinical trial within 28 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis
Single-cell Sequencing of BLF is detected before treatment, and then patients will receive the treatment of Radiation Pneumonitis according to the result.
Genetic: single-cell sequencing
Treatment is given according to the results of single-cell sequencing.
Experimental: Single-cell Sequencing of BLF to Guide the Treatment of Immune Checkpoint Inhibitor Pneumonitis
Single-cell Sequencing of BLF is detected before treatment, and then patients will receive the treatment of Immune Checkpoint Inhibitor Pneumonitis according to the result.
Genetic: single-cell sequencing
Treatment is given according to the results of single-cell sequencing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 8 weeks
Tumor diameter is measured before and 8 weeks after treatment. Area alleviated by lung shadow or ground-glass changes more than 50% was significant; The alleviating area of lung shadow or ground-glass change was 20% ~ 50%. Area alleviated by shadow or ground-glass changes in lung after treatment. 20% or worse than before treatment is ineffective.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinqiao Hospital of Chongqing

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianguo Sun, doctor, Xinqiao Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XQonc-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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