Status:
RECRUITING
A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer
Lead Sponsor:
Jinzhou Medical University
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
Conditions:
NSCLC, Stage III
NSCLC, Stage IV
Eligibility:
MALE
60+ years
Phase:
NA
Brief Summary
Androgen Deprivation Therapy (ADT) triggers thymic revitalization and increases thymic output, enhancing baseline anti-tumor immunity and responses to immunotherapies. Anti-tumor synergism has been id...
Detailed Description
Immune checkpoint blockades (ICBs) are widely used in the clinical treatment of lung cancer. Studies have shown that the quantity and function of tumor-infiltrating lymphocytes (TILs) are associated w...
Eligibility Criteria
Inclusion
- Male patients aged ≥60 years.
- ECOG performance status score of 0 \~1.
- Expected survival time of more than 3 months.
- Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC.
- Patients who have not previously received any anti-PD-1 treatment.
- Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria.
- At least one tumor lesion meeting the following criteria:
- No prior local treatments such as radiotherapy
- Not biopsied during the screening period (if biopsy needed, baseline tumor assessment at least 14 days after the screening biopsy).
- Measurable at baseline (longest diameter of the lesion ≥10 mm; For a lymph node, short diameter ≥15 mm).
- If only one measurable lesion, no prior local treatments such as radiotherapy.
- Ability to understand and voluntarily sign a written informed consent form.
- Willingness to follow the study protocol and follow-up examinations.
Exclusion
- Exclusion of cases that do not meet the inclusion criteria
Key Trial Info
Start Date :
December 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06512207
Start Date
December 3 2023
End Date
June 1 2026
Last Update
September 9 2025
Active Locations (1)
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1
The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052