Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT07177456
Eligibility Criteria:
Inclusion Criteria:
1. Ages 18-75 years,with no restriction on gender;
2. History of chest radiotherapy;
3. Diagnosed with grade 2-3 radiation-induced lung injury according to CTCAE 4.0 classification criteria in "Diagnosis and Treatment of Radiation-induced Lung Injury";
4. Inadequate response to conventional treatment for two weeks, with no relief or progressive worsening of symptoms;
5. Well-controlled tumor for ≥3 months;
6. No significant liver or kidney dysfunction: ALT, AST ≤ 3 times the upper limit of normal, serum Cr and BUN ≤ 2 times the upper limit of normal;
7. Expected survival ≥ 3 months;
8. Informed consent signed voluntarily by the patient;
9. Willing and able to receive treatment and follow-up as required by the protocol, and able to comply with basic treatment as directed by the physician.
Exclusion Criteria:
1. Severe cardiac insufficiency (such as NYHA class III or IV), uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg);
2. Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;
3. ECOG score ≥2;
4. Currently participating in or participated in other clinical trials within 4 weeks;
5. History of allergies or known allergy to the study preparation;
6. Patients with psychiatric disorders who cannot cooperate with treatment; (7) Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07177456
Study Brief:
Protocol Section:
NCT07177456