NCT06512207 A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer
| NCT ID | NCT06512207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jinzhou Medical University |
| Condition | NSCLC, Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-03 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-12-03 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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 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. Exclusion Criteria: * Exclusion of cases that do not meet the inclusion criteria
Contact & Investigator
Yu Zhang, Professor
PRINCIPAL INVESTIGATOR
Jinzhou Medical University
Frequently Asked Questions
Who can join the NCT06512207 clinical trial?
This trial is open to male participants only, aged 60 Years or older, studying NSCLC, Stage III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06512207 currently recruiting?
Yes, NCT06512207 is actively recruiting participants. Contact the research team at weiwangzhi@jzmu.edu.cn for enrollment information.
Where is the NCT06512207 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT06512207 clinical trial?
NCT06512207 is sponsored by Jinzhou Medical University. The principal investigator is Yu Zhang, Professor at Jinzhou Medical University. The trial plans to enroll 80 participants.