A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer
Recruiting · NCT06512207 · Interventional (participants receive a specific treatment) · Lead sponsor: Jinzhou Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Leuprorelin acetate + SintilimabSintilimab
What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Exclusion of cases that do not meet the inclusion criteria
Where it is running
1 location listed.
- The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China