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Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC

Primary Purpose

Lung Cancer, Immune Checkpoint Inhibitor, Radiotherapy

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Super-hyperfractionation Pulse Radiotherapy
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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. Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic therapy within 14 days before enrollment. 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. Known history of HIV infection. Receive any other investigational drug treatment or participate in other clinical trials within 28 days. There are no contraindications to stereotactic radiotherapy and immune checkpoint inhibitors.

Sites / Locations

  • the second affiliated hospital of Army medical universityRecruiting
  • Jianguo Sun

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor

Arm 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

iORR
The objective response rate away from the radiation field

Full Information

First Posted
February 12, 2023
Last Updated
July 14, 2023
Sponsor
Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT05754203
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Immune Checkpoint Inhibitor, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Super-hyperfractionation Pulse Radiotherapy
Other Intervention Name(s)
Immune Checkpoint Inhibitor
Intervention 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.
Primary Outcome Measure Information:
Title
objective response rate
Description
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 weeks
Secondary Outcome Measure Information:
Title
iORR
Description
The objective response rate away from the radiation field
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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. Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic therapy within 14 days before enrollment. 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. Known history of HIV infection. Receive any other investigational drug treatment or participate in other clinical trials within 28 days. There are no contraindications to stereotactic radiotherapy and immune checkpoint inhibitors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianguo Sun, doctor
Phone
+862368774490
Email
sunjianguo@tmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lin-Peng Zheng
Phone
+862368774395
Email
zlpxiangya@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianguo Sun
Organizational Affiliation
Department of Oncology, Xinqiao Hospital, Army Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the second affiliated hospital of Army medical university
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
40037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianguo sun, Phd
Phone
023-68774490
Email
sunjg09@aliyun.com
Facility Name
Jianguo Sun
City
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianguo Sun
Phone
+862368774490
Email
sunjianguo@tmmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC

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