Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
-
Male patients aged ≥60 years.
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ECOG performance status score of 0 ~1.
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Expected survival time of more than 3 months.
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Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC.
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Patients who have not previously received any anti-PD-1 treatment.
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Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria.
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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.
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Ability to understand and voluntarily sign a written informed consent form.
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Willingness to follow the study protocol and follow-up examinations.
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
Trial Site Locations
Total: 1 location
1
The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
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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