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

Primary Purpose

Pneumonitis

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

single-cell sequencing

About this trial

This is an interventional treatment trial for Pneumonitis focused on measuring Single-cell Sequencing, Radiation Pneumonitis, Immune Checkpoint Inhibitor Pneumonitis, Bronchoalveolar Lavage Fluid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;
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.
≥18 years old, less than 75 years old;
ECOG PS score 0-3 in the Eastern Tumor Collaboration group;
Patients without contraindications to alveolar lavage;

Exclusion Criteria:

Poor patient compliance and violation of test regulations;
Liver and kidney dysfunction, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
Had any medical condition requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment;
Severe infection occurred within 4 weeks prior to enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment;
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;
Known history of HIV infection;
Received any other investigational drug or participated in any other clinical trial within 28 days.

Sites / Locations

Xinqiao HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis

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

Arm Description

Single-cell Sequencing of BLF is detected before treatment, and then patients will receive the treatment of Radiation Pneumonitis according to the result.

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.

Outcomes

Primary Outcome Measures

Response rate

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05455034

First Posted

June 30, 2022

Last Updated

July 14, 2023

Sponsor

Xinqiao Hospital of Chongqing

1. Study Identification

Unique Protocol Identification Number

NCT05455034

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinqiao Hospital of Chongqing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonitis

Keywords

Single-cell Sequencing, Radiation Pneumonitis, Immune Checkpoint Inhibitor Pneumonitis, Bronchoalveolar Lavage Fluid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis

Arm Type

Experimental

Arm Description

Single-cell Sequencing of BLF is detected before treatment, and then patients will receive the treatment of Radiation Pneumonitis according to the result.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Intervention Type

Genetic

Intervention Name(s)

single-cell sequencing

Intervention Description

Treatment is given according to the results of single-cell sequencing.

Primary Outcome Measure Information:

Title

Response rate

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; 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. ≥18 years old, less than 75 years old; ECOG PS score 0-3 in the Eastern Tumor Collaboration group; Patients without contraindications to alveolar lavage; Exclusion Criteria: Poor patient compliance and violation of test regulations; Liver and kidney dysfunction, such as myocardial infarction, angina pectoris, liver transaminase significantly increased; Had any medical condition requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment; Severe infection occurred within 4 weeks prior to enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia; Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment; 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; Known history of HIV infection; Received any other investigational drug or participated in any other clinical trial within 28 days.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianguo Sun, doctor

Phone

023-68774490

sunjianguo@tmmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianguo Sun, doctor

Organizational Affiliation

Xinqiao Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xinqiao Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianguo Sun, doctor

Phone

023-68774490

sunjianguo@tmmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28787399

Citation

Papalexi E, Satija R. Single-cell RNA sequencing to explore immune cell heterogeneity. Nat Rev Immunol. 2018 Jan;18(1):35-45. doi: 10.1038/nri.2017.76. Epub 2017 Aug 7.

Results Reference

background

PubMed Identifier

32398875

Citation

Liao M, Liu Y, Yuan J, Wen Y, Xu G, Zhao J, Cheng L, Li J, Wang X, Wang F, Liu L, Amit I, Zhang S, Zhang Z. Single-cell landscape of bronchoalveolar immune cells in patients with COVID-19. Nat Med. 2020 Jun;26(6):842-844. doi: 10.1038/s41591-020-0901-9. Epub 2020 May 12.

Results Reference

background

PubMed Identifier

26544934

Citation

Grun D, van Oudenaarden A. Design and Analysis of Single-Cell Sequencing Experiments. Cell. 2015 Nov 5;163(4):799-810. doi: 10.1016/j.cell.2015.10.039.

Results Reference

result

Learn more about this trial

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

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