A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer

Last updated: September 2, 2025
Sponsor: Jinzhou Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Sintilimab

Leuprorelin acetate + Sintilimab

Clinical Study ID

NCT06512207
NSFC-32230037
  • Ages > 60
  • Male

Study 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 Criteria

Inclusion

3.Inclusion Criteria:

  1. Male patients aged ≥60 years.

  2. ECOG performance status score of 0 ~1.

  3. Expected survival time of more than 3 months.

  4. Histologically or cytologically diagnosed advanced lung cancer according to the TNMstaging system established by AJCC.

  5. Patients who have not previously received any anti-PD-1 treatment.

  6. Patients with adequate bone marrow function, no significant hepatic, renal, orcoagulation dysfunction as per laboratory test criteria.

  7. 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 tumorassessment at least 14 days after the screening biopsy).

  • Measurable at baseline (longest diameter of the lesion ≥10 mm; For a lymphnode, short diameter ≥15 mm).

  • If only one measurable lesion, no prior local treatments such as radiotherapy.

  1. Ability to understand and voluntarily sign a written informed consent form.

  2. Willingness to follow the study protocol and follow-up examinations.

Exclusion

Exclusion Criteria:

  • Exclusion of cases that do not meet the inclusion criteria

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Sintilimab
Phase:
Study Start date:
December 03, 2023
Estimated Completion Date:
June 30, 2026

Study 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 with the effectiveness of PD-1 inhibitors in treating advanced NSCLC. The thymus is crucial for the differentiation, development, and maturation of T cells. With age, thymic atrophy leads to immunosenescence, significantly affecting baseline anti-tumor immunity and responses to immunotherapies. Preliminary findings have indicated that androgen deprivation therapy (ADT) not only directly induces apoptosis in prostate cancer cells but also may exert anti-tumor effects by promoting thymic regeneration. Furthermore, anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. Therefore, this study aims to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.

Connect with a study center

  • The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Active - Recruiting

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