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

NCT ID: NCT05455034

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-12-30

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.

Conditions

Pneumonitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

single-cell sequencing

Intervention Type: 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 is detected before treatment, and then patients will receive the treatment of Immune Checkpoint Inhibitor Pneumonitis according to the result.

Group Type: EXPERIMENTAL

single-cell sequencing

Intervention Type: GENETIC

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

Interventions

single-cell sequencing

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

Intervention Type: GENETIC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Jianguo Sun

Deputy director of oncology department, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianguo Sun, doctor

Role: PRINCIPAL_INVESTIGATOR

Xinqiao Hospital

Locations

Xinqiao Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianguo Sun, doctor

Role: CONTACT

sunjianguo@tmmu.edu.cn

023-68774490

Facility Contacts

Jianguo Sun, doctor

Role: primary

sunjianguo@tmmu.edu.cn

023-68774490

References

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.

Reference Type: BACKGROUND

PMID: 28787399 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32398875 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26544934 (View on PubMed)

Other Identifiers

XQonc-019

Identifier Type: -

Identifier Source: org_study_id