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

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About this study

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.

Condition
NSCLC, Stage III, NSCLC, Stage IV
Tested
Leuprorelin acetate + Sintilimab, Sintilimab
Sponsor
Jinzhou Medical University

Who can join

Age
60 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 17

  • Minimum age: 60 years
  • Eligible sex: Male
  • Study condition: NSCLC, Stage III, NSCLC, Stage IV
  • 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 1

  • Exclusion of cases that do not meet the inclusion criteria

Where

1 site, 1 recruiting

The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.