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Hypothyroidism induced by neoadjuvant immunecheckpoint inhibitors (ICIs) aggravates radiation-inducedpulmonary fibrosis (RIPF) in lung cancer patientsundergoing hypofractionated radiotherapy (HFRT) andconcurrent ICIs

Hypothyroidism induced by neoadjuvant immunecheckpoint inhibitors (ICIs) aggravates radiation-inducedpulmonary fibrosis (RIPF) in lung cancer patientsundergoing hypofractionated radiotherapy (HFRT) andconcurrent ICIs

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127150
Enrollment
Unknown
Registered
2026-06-25
Start date
2025-07-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

observed group:Chemo-Immunotherapy combined with hyperfractionated radiotherapy

Sponsors

Tianjin Cancer Hospital Airport Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. On the day of signing the informed consent form, the age is >= 18 years old. 2. The World Health Organization physical condition score is 0 or 1 (on a 5-point scale; the higher the score, the more severe the disability). 3. The expected survival period is >= 12 weeks. 4. Lung cancer diagnosed by histological or cytological examination. 5. The pathological type is non-small cell carcinoma or small cell carcinoma. 6. The non-small cell carcinoma stage is based on the 8th edition of the International Association for the Study of Lung Cancer (IASLC) Thoracic Oncology.

Exclusion criteria

Exclusion criteria: 1. Had previously undergone surgery or radiotherapy; 2. There are uncontrolled concurrent diseases or persistent/active infections; 3. There is an active or previously existing autoimmune disease (within the past 2 years) or primary immunodeficiency disease; 4. There is a history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease; 5. Within the previous 28 days before the first administration, any major surgery requiring general anesthesia has been performed; there are underlying medical conditions that are unfavorable for the administration of the study drug, or may affect the interpretation of results, or may cause a high risk of treatment complications for the patient; 6. Participating in another therapeutic clinical study simultaneously; 7. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
The occurrence time of radioactive lung fibrosis;

Countries

China

Contacts

Public ContactWang Yuwen

Tianjin Cancer Hospital Airport Hospital

13752267669@163.com+86 137 5226 7669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026