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

NCT05455034 | Recruiting Phase 1 DMC

• 1 other identifier: XQonc-019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

single-cell sequencing GENETIC

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

Xinqiao Hospital

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 28787399 BACKGROUND

• 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.

  PMID: 32398875 BACKGROUND

• 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.

  PMID: 26544934 RESULT

MeSH Terms

Conditions

Pneumonia; Radiation Pneumonitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Wounds and Injuries

Study Officials

• Jianguo Sun, doctor

  Xinqiao Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianguo Sun, doctor

CONTACT

023-68774490; sunjianguo@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of oncology department, Clinical Professor

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 13, 2022
• Study Start: August 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)