Effect of Low-dose Radiotherapy on Tumor Immune Microenvironment in Oligometastases of NSCLC Afte… (NCT06331585) | Clinical Trial Compass
WithdrawnPhase 2
Effect of Low-dose Radiotherapy on Tumor Immune Microenvironment in Oligometastases of NSCLC After Immunotherapy
Stopped: work commitments
China0Started 2024-03-18
Plain-language summary
The purpose of this phase â…¡ trial was to investigate the effect of low-dose radiotherapy (LDRT) on the tumor immune microenvironment (TME) in oligometastasis, oligoprogression, and oligopersistence of non-small cell lung cancer (NSCLC) after immunotherapy. At least 20 participants will be enrolled in this study. All will take part at Hetian District People's Hospital.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Agree to take pathologic biopsies of oligometastasis, oligoprogression, or oligopersistence lesions before and up to 24h after LDRT. And be willing and able to provide written informed consent/assent for the trial.
✓. Patients with histologically or cytologically confirmed NSCLC.
✓. Patient developed oligometastasis, oligoprogression or oligopersistence after standard immunotherapy.
✓. Be ≥18 years of age on day of signing informed consent.
✓. Be willing to undergo repeat biopsy of tumor lesions according to the study protocol.
✓. Patients who have failed the standard therapy, or who are unsuitable for standard treatment, or refuse chemotherapy.
✓. At least one measurable lesion according to RECIST 1.1. A lesion that has previously received radiotherapy can be considered a target lesion only if this lesion is clearly progressed after radiotherapy.
✓. The target lesions (irradiated lesions) are \> 5cm in in diameter
Exclusion criteria
✕. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or spinal cord compression, etc.
✕. With oncologic emergencies that require immediate treatment
✕. EGFR/ALK/ROS-1 mutation or mutation status unknown.
. Has evidence of interstitial lung disease or active and/or non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy.
✕. History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease
✕. Patients with peripheral neuropathy.
✕. Significant heart disease or impairment of cardiac function
✕. Fluid accumulating in the third space, such as pericardial effusion, pleural effusion and peritoneal effusion that remains uncontrolled by aspiration or other treatment