RecruitingPhase 2NCT06775678

Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer

A Single-centre Phase II Clinical Study of Spatially Fragmentation Radiotherapy Combined With Low-dose Radiotherapy for Reversal of Immunotherapy Combined With Chemotherapy Resistance in Locally Advanced Inoperable or Advanced Non-small Cell Lung Cancer


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

84 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study was to evaluate the effect of immunotherapy combined with spatial fractionation radiotherapy and low dose radiotherapy on the prognosis of patients with advanced lung cancer under specific dose regimens (spatial fractionation radiotherapy: high dose region: 800-1200cGy × 3f, low dose region: 100-300cGy × 5f; low dose radiotherapy area: 100-300cGy × 5f). Through the phase II clinical trial, to determine the efficacy and safety of the combined treatment model in advanced lung cancer and its effect on the immune microenvironment of patients, so as to provide scientific basis for the optimization of treatment regimen for advanced lung cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radiation technique called spatial fragmentation (a way of delivering radiation in a targeted pattern) combined with low-dose radiotherapy for people with advanced non-small cell lung cancer (NSCLC) whose cancer has stopped responding to immunotherapy and chemotherapy. **You may be eligible if...** - You are 18 years or older - You have lung cancer confirmed by biopsy (adenocarcinoma, squamous cell, or small cell) - Your cancer has progressed after receiving immunotherapy - The area being treated has not received prior radiation, or it has been at least 6 months since last radiation to that site - You have a Karnofsky score of 70 or higher and expected survival of 3+ months **You may NOT be eligible if...** - Your cancer involves malignant fluid in the chest, abdominal cavity, or has spread to the brain lining - You had a heart attack within the past 6 months or have severe heart arrhythmia - Your tumors are not suitable for radiation targeting Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSpatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy

Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy

RADIATIONConventional fractionated radiotherapy

Conventional fractionated radiotherapy


Locations(1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

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NCT06775678


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