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

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining androgen deprivation therapy (hormone-blocking treatment) with anti-PD-1 immunotherapy can improve outcomes for men with advanced lung cancer. The idea is that lowering testosterone levels may make cancer cells more vulnerable to immune attack. **You may be eligible if...** - You are a male patient aged 60 or older - You have been confirmed by biopsy to have advanced lung cancer - You have not previously received any anti-PD-1 immunotherapy - Your expected survival is more than 3 months - Your physical performance is good (ECOG 0-1) - You have adequate bone marrow and organ function - You have at least one measurable tumor lesion **You may NOT be eligible if...** - You are female (this study only enrolls males) - You have previously received anti-PD-1 immunotherapy - You are under 60 years old - Your expected survival is less than 3 months - You have serious organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


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