Actively Recruiting

Phase Not Applicable
Age: 60Years +
MALE
NCT06512207

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

Led by Jinzhou Medical University · Updated on 2025-09-09

80

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

J

Jinzhou Medical University

Lead Sponsor

T

The First Affiliated Hospital of Zhengzhou University

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  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 TNM staging 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, or coagulation 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 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.
  8. Ability to understand and voluntarily sign a written informed consent form.

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

Not Eligible

You will not qualify if you...

  • Exclusion of cases that do not meet the inclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

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Research Team

W

Wangzhi Wei

CONTACT

S

Shuangning Yang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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