Checkpoint Inhibitor Pneumonitis (CIP)
Conditions
Interventions
Intervention group:Recombinant Humanized Anti-CD25 Monoclonal Antibody Combined with Standard Clinical Management
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old, male or female; 2. Patients with solid malignant tumors confirmed by histopathology; 3. After receiving PD-1 inhibitor treatment, new pulmonary shadows appeared, and clinical evaluation diagnosed it as immune checkpoint inhibitor-related pneumonia; 4. According to the CTCAE5.0 standard, the patient is assessed as having grade 2 or 3 immune checkpoint inhibitor-related pneumonia, and the time from diagnosis confirmation to enrollment is no more than one week; 5. ECOG score is 0-2; 6. Expected survival duration >= 3 months; 7. Volunteer to join this study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Presence of active or uncontrolled severe autoimmune diseases; 2. Patients who are known to be allergic to or intolerant of the study drug; 3. Patients with clearly identified causes of other pneumonias (such as radiation pneumonia, COVID-19, and tumor infiltration of the lungs); 4. Evidence of active or uncontrolled viral infections (including hepatitis B, hepatitis C, and human immunodeficiency virus/HIV infection); 5. Having previously undergone solid organ transplantation (excluding corneal transplantation for more than 3 months) or allogeneic hematopoietic stem cell transplantation; 6. Individuals with severe lesions in vital organs such as the heart, liver, kidneys, as well as in the blood and endocrine systems; 7. Female patients who are pregnant or breastfeeding, or who cannot adopt effective contraceptive measures throughout the trial period; 8. Having severe concomitant diseases or other comorbidities that may interfere with the planned treatment, or any other conditions that make the participant unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of CIP resolution to grade <=1 at 8 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of pulmonary infection;Median remission time and recurrence rate of CIP;Cumulative Dose and Duration of Corticosteroid Use;Quality of Life Score; | — |
Countries
China
Contacts
Public ContactZhengbo Song
Zhejiang Cancer Hospital
Outcome results
None listed