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Canceled by the investigator. Study of endocrine adverse reactions associated with immune checkpoint inhibitors

Study of endocrine adverse reactions associated with immune checkpoint inhibitors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070103
Enrollment
Unknown
Registered
2023-04-02
Start date
2023-04-02
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Immune checkpoint inhibitor-related endocrine diseases

Interventions

Patients with pituitary related adverse reactions induced by anti PD-1 monoclonal antibody:N/A

Sponsors

The Third Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. History of anti-PD-1 monoclonal antibody application; 2. Normal pituitary function before anti-PD-1 monoclonal antibody treatment and normal pituitary morphology on MRI; 3. Nausea, vomiting, loss of appetite, fever, malaise, headache, eye muscle palsy, loss of vision and/or visual field defects, coma, etc. after anti-PD-1 monoclonal antibody treatment; 4. Pituitary hormone basal values below normal after treatment and pituitary hormone levels cannot be excited by hormone excitation test; 5. Imaging: with/without pituitary enlargement and no signs of tumor brain metastasis.

Exclusion criteria

Exclusion criteria: 1. Patients with brain metastases from primary tumor lesions, pituitary tumors, craniopharyngiomas, intracranial germ cell tumors, Langerhans cell histiocytosis, nodal disease, granulomatous vasculitis, systemic lupus erythematosus, tuberculosis, syphilis, and other intracranial localized occurrences and secondary pituitary inflammation due to systemic systemic immune diseases involving the pituitary gland; 2. Patients requiring tyrosine kinase inhibitors, requiring long-term massive glucocorticoid therapy, and severe adverse effects in other organs after ICPis therapy, such as ICPis-related myocarditis, hepatitis, pneumonia, and enterocolitis requiring moderate to high doses of glucocorticoid therapy.

Design outcomes

Primary

MeasureTime frame
Gender;Age;Thyroid stimulating hormone;Adrenocorticotropic hormone;Luteinizing hormone;Follicle-stimulating hormone;

Countries

China

Contacts

Public ContactShuchang Wang

The Third Hospital of Hebei Medical University

wang-sy2007@163.com+86 311 88603000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026