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

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: Recruiting
• Conditions: Pneumonitis
• Intervention / Treatment: Genetic: single-cell sequencing

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: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jianguo Sun, doctor; Phone Number: 023-68774490; Email: sunjianguo@tmmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • Recruiting
      • Xinqiao Hospital
      • Contact: Jianguo Sun, doctor; Phone Number: 023-68774490; Email: sunjianguo@tmmu.edu.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing
• Investigators: Principal Investigator: Jianguo Sun, doctor, Xinqiao Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Radiation Pneumonitis; Single-cell Sequencing; Immune Checkpoint Inhibitor Pneumonitis; Bronchoalveolar Lavage Fluid
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Pneumonia; Radiation Pneumonitis
• Other Study ID 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