A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer
A Clinical Investigation on the Efficacy of Leuprorelin Acetate (Androgen Deprivation Therapy) Combined With Sintilimab (Anti-PD-1) in Advanced Lung Cancer
Jinzhou Medical University
80 participants
Dec 3, 2023
INTERVENTIONAL
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 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.
Eligibility
Inclusion Criteria13
- 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.
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Interventions
Leuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely used in clinical practice.
PD-1 inhibitor
Locations(1)
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NCT06512207