ArticleJMIR research protocols2024
Ultrasound-Guided High-Intensity Focused Ultrasound Combined With PD-1 Blockade in Patients With Liver Metastases From Lung Cancer: Protocol for a Single-Arm Phase 2 Trial.
Article in JMIR research protocols, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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2 citing papers in PubMed.
- Heterogeneity of the liver cancer tumor microenvironment: mitochondrial metabolism and causal inference through Mendelian randomization.Discover oncology · 2025Article
- Application and prospects of ultrasound combined with immunotherapy in cancer treatment of intensive care.Frontiers in immunology · 2025Review
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11 authors.
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Abstract
backgroundWhile immunotherapy has revolutionized oncological management, its efficacy in lung cancer patients with liver metastases remains limited, potentially due to the unique immunosuppressive microenvironment of the liver. Local liver treatment has been shown to enhance the immunotherapy response, and high-intensity focused ultrasound (HIFU), a minimally invasive local treatment, has demonstrated promising results in combination with immunotherapy. However, clinical data regarding HIFU in lung cancer with liver metastases are limited.
objectiveWe designed the HILL (Ultrasound-Guided High-Intensity Focused Ultrasound Combined With PD-1 Blockade in Patients With Liver Metastases From Lung Cancer) study to investigate the effectiveness and safety of HIFU in combination with immunotherapy for lung cancer with liver metastases.
methodsThe HILL study is a single-armed, single-center, phase 2 clinical trial that will enroll 30 patients with lung cancer and liver metastases. The treatment regimen involves administering HIFU to liver metastases 1 week before the first dose of a programmed cell death protein (PD)-1 blockade, which is then administered every 3 weeks. The primary aim is to determine the overall response rate based on immune-related response criteria. Secondary aims include safety, progression-free survival, overall response, overall survival, and quality of life. Exploratory studies will also be conducted using whole blood, plasma, archival cancer tissue, and tumor biopsies during progression or relapse to identify potential biomarkers.
resultsThe study was funded on March 14, 2022, and received ethical approval on April 27, 2022. Clinical trial registration was completed by June 10, 2022, with participant recruitment beginning on July 10, 2022. Data collection commenced on July 14, 2022, with the enrollment of the first patient. By April 2024, 6 participants had been recruited. The results are expected to be published in December 2026.
conclusionsThis study seeks to improve treatment outcomes for lung cancer patients with liver metastases by combining HIFU and PD-1 inhibition. The study also aims to identify potential biomarkers through exploratory research that can aid in selecting patients for optimized outcomes in the future.
trial registrationChinese Clinical Trial Registry ChiCTR2200061076; https://www.chictr.org.cn/showproj.html?proj=170967. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59152.
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