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

ConditionPneumonitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXinqiao Hospital of Chongqing

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • single-cell sequencing

    Genetic

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Single-cell Sequencing of BLF to Guide the Treatment of Radiation PneumonitisExperimental treatment 1 intervention
Group B: Single-cell Sequencing of BLF to Guide the Treatment of Immune Checkpoint Inhibitor PneumonitisExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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