Clinical trial NCT05754203: Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC
Official title: Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor for Advanced Non-small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Immune Checkpoint Inhibitor
Radiotherapy
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: objective response rate
timeFrame: 12 weeks
Secondary outcomes:
measure: iORR
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the second affiliated hospital of Army medical university
state: Chongqing
city: Chongqing
country: China
facility: Jianguo Sun
Study officials:
affiliation: Department of Oncology, Xinqiao Hospital, Army Medical University
name: Jianguo Sun
role: PRINCIPAL_INVESTIGATOR
References: