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Clinical Trials in China / NCT05455034
Recruiting Phase 1/2

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

NCT05455034 · tracked via the Priya Life Science China tracker
Sponsor
Xinqiao Hospital of Chongqing
Phase
Phase 1/2
Started
2023-08-01
Last updated
2025-07-14

Condition(s) studied

Pneumonitis

Investigational drug(s) / intervention(s)

single-cell sequencing

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xinqiao Hospital Chongqing Chongqing Municipality Recruiting

More Xinqiao Hospital of Chongqing trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05455034 on ClinicalTrials.gov ↗ ← All trials in China