Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXinqiao Hospital of Chongqing
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
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).
Age ≥ 18 and less than 75.
Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) 0-3.
Disqualifiers
The participant's compliance is poor and the test regulations are violated.
Dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, and significant increase of liver transaminase.
Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment.
Serious infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia.
Trial design
Design model
Single group
Treatments tested in this trial
Super-hyperfractionation Pulse Radiotherapy
RadiationRadiotherapy 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint InhibitorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
objective response rate
The proportion of patients with tumor volume reduced by 30% and maintained for more than 4 weeks. Sum of the proportions of complete response (CR) and partial response (PR)
Time frame
12 weeksSecondary outcomes
1
iORR
The objective response rate away from the radiation field
Time frame
24 weeksSponsors and contacts
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Source ClinicalTrials.gov