Clinical trial NCT05455034: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pneumonitis
Keywords: Single-cell Sequencing
Radiation Pneumonitis
Immune Checkpoint Inhibitor Pneumonitis
Bronchoalveolar Lavage Fluid
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Response rate
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital
state: Chongqing
Study officials:
affiliation: Xinqiao Hospital
name: Jianguo Sun, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.