RecruitingNot ApplicableNCT06512207

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


Sponsor

Jinzhou Medical University

Enrollment

80 participants

Start Date

Dec 3, 2023

Study Type

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

Sex: MALEMin Age: 60 Years

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

DRUGLeuprorelin acetate + Sintilimab

Leuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely used in clinical practice.

DRUGSintilimab

PD-1 inhibitor


Locations(1)

The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06512207