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Search / Trial NCT05754203

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

Launched by XINQIAO HOSPITAL OF CHONGQING · Feb 22, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC). Researchers are combining a special type of radiation therapy, called super-hyperfractionation pulse radiotherapy, with immune checkpoint inhibitors (ICIs). The goal is to enhance the body’s immune response against the cancer while minimizing damage to healthy tissue. This innovative method aims to make the cancer cells more recognizable to the immune system, potentially leading to better treatment outcomes.

To participate in this trial, you need to be between 18 and 75 years old and have been diagnosed with stage IIIB or higher NSCLC. You should also be able to follow the study guidelines and have a good performance status, meaning you can carry out daily activities with minimal assistance. If you join the trial, you can expect to receive both the radiation therapy and the immune treatment while being closely monitored by the research team. It's important to note that individuals with certain health conditions or recent infections may not be eligible for this study. This trial is currently recruiting participants, so if you think you might qualify, it could be a valuable opportunity to explore new treatment options.

Gender

ALL

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.

About Xinqiao Hospital Of Chongqing

Xinqiao Hospital of Chongqing is a prestigious medical institution affiliated with the Third Military Medical University, renowned for its commitment to advanced healthcare and clinical research. With a strong emphasis on innovation and patient-centered care, the hospital operates state-of-the-art facilities and employs a multidisciplinary approach to treatment and research. As a clinical trial sponsor, Xinqiao Hospital is dedicated to advancing medical knowledge and improving patient outcomes through rigorous scientific investigation, contributing to the development of new therapies and healthcare solutions. Its collaborative efforts with various research entities underscore its role as a leader in the field of clinical trials and medical research in China.

Locations

Chongqing, Chongqing, China

Chongqing, , China

Patients applied

0 patients applied

Trial Officials

Jianguo Sun

Principal Investigator

Department of Oncology, Xinqiao Hospital, Army Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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