A Clinical Investigation on the Efficacy of Leuprorelin Acetate (Androgen Deprivation Therapy) Combined With Sintilimab (Anti-PD-1) in Advanced Lung Cancer
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 identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. This study is to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.
• Male patients aged ≥60 years.
• ECOG performance status score of 0 \
• 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.