NCT06512207Recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 6 Jul 2024
- Start date
- Dec 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Jinzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT06512207
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Dec 2023 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Exclusion of cases that do not meet the inclusion criteria
Criteria the registry did not label
- 3.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.
Age in the registry: 60 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.