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Trial Title:
Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC
NCT ID:
NCT05754203
Condition:
Lung Cancer
Immune Checkpoint Inhibitor
Radiotherapy
Conditions: Official terms:
Lung Neoplasms
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Super-hyperfractionation Pulse Radiotherapy
Description:
Radiotherapy design: a single dose of 0.5Gy, 16 consecutive pulses with an interval of 3
minutes (0.5Gy * 16F), total dose DT: 8Gy; Immunotherapy: PD-1/PD-L1 monoclonal
antibodies conforming to CSCO guidelines for lung cancer indications, including
Carrilizumab, Tirelizumab, Teripril, Paborizumab, etc., conventional therapeutic dose,
Q3W, until progression or the investigator judges that there is no longer clinical
benefit or intolerable side effects.
Arm group label:
Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor
Other name:
Immune Checkpoint Inhibitor
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the second affiliated hospital of Army medical university
Address:
City:
Chongqing
Zip:
40037
Country:
China
Status:
Recruiting
Contact:
Last name:
jianguo sun, Phd
Phone:
023-68774490
Email:
sunjg09@aliyun.com
Facility:
Name:
Jianguo Sun
Address:
City:
Chongqing
Zip:
400000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianguo Sun
Phone:
+862368774490
Email:
sunjianguo@tmmu.edu.cn
Start date:
August 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Xinqiao Hospital of Chongqing
Agency class:
Other
Source:
Xinqiao Hospital of Chongqing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754203
