NCT05754203 Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC
| NCT ID | NCT05754203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xinqiao Hospital of Chongqing |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2026-03-01 |
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 40 participants in total. It began in 2023-08-01 with a primary completion date of 2026-03-01.
⚠ 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
Investigators intend to combine low-dose hypersensitivity with high-dose immunopotentiation effect, and use super-hyperfractionation pulse radiotherapy, which is expected to achieve the effect of in situ vaccine that can enhance tumor killing, protect normal tissues, reduce immune cell damage and enhance tumor immunogenicity at the same time, and play a stronger immunopotentiation effect in combined immunotherapy. Thereby inducing a stronger abscopal effect of radiotherapy.
Eligibility 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.
Contact & Investigator
Jianguo Sun
PRINCIPAL INVESTIGATOR
Department of Oncology, Xinqiao Hospital, Army Medical University
Frequently Asked Questions
Who can join the NCT05754203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05754203 currently recruiting?
Yes, NCT05754203 is actively recruiting participants. Contact the research team at sunjianguo@tmmu.edu.cn for enrollment information.
Where is the NCT05754203 trial being conducted?
This trial is being conducted at Chongqing, China, Chongqing, China.
Who is sponsoring the NCT05754203 clinical trial?
NCT05754203 is sponsored by Xinqiao Hospital of Chongqing. The principal investigator is Jianguo Sun at Department of Oncology, Xinqiao Hospital, Army Medical University. The trial plans to enroll 40 participants.
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