Combining advanced radiotherapy with immune therapy for lung cancer
Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor for Advanced Non-small Cell Lung Cancer.
This study is testing a new treatment for advanced lung cancer that combines special radiation therapy with immune therapy to see if it can help patients feel better and improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xinqiao Hospital of Chongqing Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Chongqing, Chongqing Municipality and 1 other locations) |
| Trial ID | NCT05754203 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of a novel treatment approach that combines super-hyperfractionation pulse radiotherapy with immune checkpoint inhibitors for patients with advanced non-small cell lung cancer (NSCLC). The methodology involves using low-dose hypersensitivity alongside high-dose immunopotentiation to enhance tumor killing while protecting normal tissues. The goal is to induce a stronger immune response and improve the overall effectiveness of the treatment, potentially leading to better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with stage IIIB or above non-small cell lung cancer who meet specific radiotherapy and immunotherapy criteria.
Not a fit: Patients with significant organ dysfunction or those requiring systemic immunosuppressive treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced lung cancer.
How similar studies have performed: While the combination of radiotherapy and immunotherapy is being explored in various studies, this specific approach of super-hyperfractionation pulse radiotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent. 2. Participants diagnosed with stage IIIB or above non-small cell lung cancer confirmed by histopathology (whether newly diagnosed or not) meet the requirements of SBRT radiotherapy (mass limited, less than 5 cm) and immune checkpoint inhibitor therapy (according to CSCO guidelines). 3. Age ≥ 18 and less than 75. 4. Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) 0-3. Exclusion Criteria 1. The participant's compliance is poor and the test regulations are violated. 2. Dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, and significant increase of liver transaminase. 3. Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment. 4. Serious infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia. 5. Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic therapy within 14 days before enrollment. 6. Participants with untreated chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B, HBsAg carriers, treated and stable hepatitis B carriers (HBV DNA \< 500 IU/mL), and cured hepatitis C patients can be included in the group. 7. Known history of HIV infection. 8. Receive any other investigational drug treatment or participate in other clinical trials within 28 days. 9. There are no contraindications to stereotactic radiotherapy and immune checkpoint inhibitors.
Where this trial is running
Chongqing, Chongqing Municipality and 1 other locations
- the second affiliated hospital of Army medical university — Chongqing, Chongqing Municipality, China (Recruiting)
- Jianguo Sun — Chongqing, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Jianguo Sun — Department of Oncology, Xinqiao Hospital, Army Medical University
- Study coordinator: Jianguo Sun, doctor
- Email: sunjianguo@tmmu.edu.cn
- Phone: +862368774490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.